3-Hour Virtual Seminar on Bootcamp on Quality Management System (QMS) - Per ISO and US FDA's GMPs by: John E Lincoln View Details Date: 04 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions by: Mike Thomas View Details Date: 04 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Date: 04 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry by: Michael Esposito View Details Date: 04 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
The Transfer of Validated Methods by: John C. Fetzer View Details Date: 06 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms by: Roger Cowan View Details Date: 06 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 75 Minutes Price: $150.00
Secrets to Writing Effective SOPs for Medical Device QMS by: Susanne Manz View Details Date: 06 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
ChatGPT & AI for Project Management for FDA-Regulated Companies by: Charles H. Paul View Details Date: 06 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations by: Robert J. Russell View Details Date: 07 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 6 Hours Price: $545.00
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification by: David Nettleton View Details Date: 07 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 2 Hours Price: $190.00
ChatGPT for Excel Essentials Made Easy by: Ray Evans View Details Date: 07 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
4-Hour Virtual Seminar on Bootcamp on Excel by: Tom Fragale View Details Date: 08 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement by: Carolyn Troiano View Details Date: 08 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures by: Edwin Waldbusser View Details Date: 08 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
ChatGPT for Excel Intermediate Masterclass by: Ray Evans View Details Date: 08 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
The Importance of Packaging and Labeling in Pharmaceutical Product Development by: Michael Esposito View Details Date: 11 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
2-Day Virtual Seminar on Technical Writing in the Life Sciences - Writing Regulatory Documentation for Consistency, Clarity, Accuracy, and Utility by: Charles H. Paul View Details Date: 11 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 2 Days Price: $995.00
Device Changes, FDA Changes, and the 510(k) by: John E Lincoln View Details Date: 11 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
How to Prepare for and Host an FDA Inspection and Respond to 483's by: Edwin Waldbusser View Details Date: 11 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
How to Reduce Human Error in a GMP Manufacturing/Floor by: Ginette Collazo View Details Date: 12 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico by: Robert J. Russell View Details Date: 12 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to meet FDA and International Quality Standards by: Roger Cowan View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
ChatGPT for Excel by: Tom Fragale View Details Date: 13 November, 2024 Time: 12:00 PM PST | 03:00 PM EST Duration: 60 Minutes Price: $150.00
Quality Management 101: An Enterprise Maintenance Professional's Guide by: John E Lincoln View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Analytical Method Validation Under Good Laboratory Practices - GLPs by: John C. Fetzer View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Excel Basics - Data Visualization - Creating Effective Charts by: Mike Thomas View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Death By CAPA - Does your CAPA Program Need a CAPA? by: Susanne Manz View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Powerpoint Creating & Presenting a Complete Slide Show by: Ray Evans View Details Date: 13 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
2-Day Virtual Seminar on Project Management for Non-Project Managers - PM in the Life Sciences - Pharmaceutical/ Biotechnology and Medical Devices by: Charles H. Paul View Details Date: 14 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 2 Days Price: $995.00
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Date: 14 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
Strategies to Prevent Manufacture and Distribution of Substandard Medications by: Michael Esposito View Details Date: 15 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel - Formulas and Functions 101 by: Mike Thomas View Details Date: 15 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
The Most Common Problems in FDA Software Validation & Verification by: John E Lincoln View Details Date: 15 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel Formula Functions & Automatic Calculation Powerpoint Easy by: Ray Evans View Details Date: 15 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Medical Device Software Validation Meeting FDA Regulations by: Edwin Waldbusser View Details Date: 15 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Excel - Essential Tips and Tricks for the New User by: Mike Thomas View Details Date: 18 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
3-Hour Virtual Seminar on Chat GPT for Project Management in FDA Regulated Environment by: Charles H. Paul View Details Date: 18 November, 2024 Time: 09:00 AM PST | 12:00 PM EST Duration: 3 Hours Price: $290.00
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations by: Robert J. Russell View Details Date: 18 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements by: John E Lincoln View Details Date: 18 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
FDA Regulation of Artificial Intelligence/ Machine Learning by: Edwin Waldbusser View Details Date: 18 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements by: Roger Cowan View Details Date: 20 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
HPLC Analytical Method Development and Validation by: John C. Fetzer View Details Date: 20 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Human Error Reduction Techniques for Floor Supervisors by: Ginette Collazo View Details Date: 20 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel ChatGPT MasterClass 3 - Work Smarter and Faster by: Ray Evans View Details Date: 20 November, 2024 Time: 11:30 AM PST | 02:30 PM EST Duration: 90 Minutes Price: $150.00
Essentials of Validation - IQ OQ PQ by: Susanne Manz View Details Date: 20 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Device Changes, FDA Changes, and the 510(k) by: John E Lincoln View Details Date: 20 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
4-Hour Virtual Seminar on Managing Large Amounts of Data with Excel Charts, Power Query, Pivot Tables, and PowerPivot by: Tom Fragale View Details Date: 21 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
2-Day Virtual Seminar on Effective Technical Writing in the Life Sciences by: Charles H. Paul View Details Date: 21 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 2 Days Price: $995.00
Using a Learning Management System (LMS) to Develop Pharma Training Curricula by: Michael Esposito View Details Date: 21 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel Pivot Tables, Pivot Charts, Slicers, and Timelines by: Tom Fragale View Details Date: 22 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations by: John E Lincoln View Details Date: 22 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 6 Hours Price: $545.00
Excel ChatGPT Masterclass 4 - Gain the Competitive Advantage by: Ray Evans View Details Date: 25 November, 2024 Time: 08:30 AM PST | 11:30 AM EST Duration: 90 Minutes Price: $150.00
How to Write SOPs for Human Error Reduction by: Ginette Collazo View Details Date: 26 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats by: Michael Esposito View Details Date: 26 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities by: Robert J. Russell View Details Date: 26 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel ChatGPT Masterclass 5 - Achieve More in Less Time by: Ray Evans View Details Date: 26 November, 2024 Time: 11:30 AM PST | 02:30 PM EST Duration: 90 Minutes Price: $150.00
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance by: Edwin Waldbusser View Details Date: 26 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
CMO Supplier Quality Agreements - What you need to know to Comply with New FDA & EU GMP Guidelines for Contract Drug Manufacture by: Roger Cowan View Details Date: 27 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
How to Deal with Bad Results Under GLP by: John C. Fetzer View Details Date: 27 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices by: Susanne Manz View Details Date: 27 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel PowerPivot and Power Query by: Tom Fragale View Details Date: 29 November, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA by: Carolyn Troiano View Details Date: 29 November, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 6 Hours Price: $545.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures by: Edwin Waldbusser View Details Date: 02 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Excel - Lists and Tables - A Beginner's Guide to Managing List-Based Data by: Mike Thomas View Details Date: 02 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA by: Carolyn Troiano View Details Date: 02 December, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 6 Hours Price: $545.00
Function, Preparation, and Execution of Job Aids in the Pharmaceutical Industry by: Michael Esposito View Details Date: 02 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
6-Hour Virtual Seminar on Inspection and Audit Readiness Training for Medical Device Manufacturers by: John E Lincoln View Details Date: 02 December, 2024 Time: 07:00 AM PST | 10:00 AM EST Duration: 6 Hours Price: $545.00
3-Hour Virtual Seminar on IQ, OQ, and PQ in the Verification and Validation Process by: Susanne Manz View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
Excel Vital Introductory Essentials with Tips & Shortcuts by: Ray Evans View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
The Transfer of Validated Methods by: John C. Fetzer View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
GMP Environmental Monitoring in Pharmaceutical Clean Rooms by: Roger Cowan View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR by: David Nettleton View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
How to Write SOPs that Avoid Human Error by: Ginette Collazo View Details Date: 04 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Scientific Writing Fundamentals - Mastering the Basics in Life Sciences Documentation by: Charles H. Paul View Details Date: 05 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
The Monte Carlo Simulations in Excel for Risky Investments by: Isaac Gottlieb View Details Date: 05 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
How to Prepare for and Host an FDA Inspection and Respond to 483's by: Edwin Waldbusser View Details Date: 06 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Excel - Mastering Lookup Functions by: Mike Thomas View Details Date: 06 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
US Market Access & Reimbursement: Medical Devices by: Robert J. Russell View Details Date: 06 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
4-Hour Virtual Seminar on Combination Product Device Supplier Management Training by: John E Lincoln View Details Date: 06 December, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
Medical Device Software Validation Meeting FDA Regulations by: Edwin Waldbusser View Details Date: 09 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil, and Mexico by: Robert J. Russell View Details Date: 09 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
The Importance of Packaging and Labeling in Pharmaceutical Product Development by: Michael Esposito View Details Date: 09 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Writing for Regulatory Success - Strategies for Quality Technical Documents by: Charles H. Paul View Details Date: 10 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
3-Hour Virtual Seminar on Mastering Excel Formulas and Functions by: Mike Thomas View Details Date: 10 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
The Human Error Toolbox: A Practical Approach to Human Error by: Ginette Collazo View Details Date: 10 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel Lookup Functions Xlookup & Error Suppression by: Ray Evans View Details Date: 11 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Project Management for Non-Project Managers - Scheduling your Project by: Charles H. Paul View Details Date: 11 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
The Data Ribbon and PivotTables by: Isaac Gottlieb View Details Date: 11 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Analytical Method Validation Under Good Laboratory Practices - GLPs by: John C. Fetzer View Details Date: 11 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Project Management for Non-Project Managers - Determining the Work that needs to be done by: Charles H. Paul View Details Date: 12 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Project Management for Non-Project Managers - How to Communicate Project Actions and Progress - Conducting Effective Project Review Meetings by: Charles H. Paul View Details Date: 13 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel - Quick Tips to Help you be More Productive by: Mike Thomas View Details Date: 13 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
4-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement by: Carolyn Troiano View Details Date: 13 December, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Date: 13 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
Strategies to Prevent Manufacture and Distribution of Substandard Medications by: Michael Esposito View Details Date: 13 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Preventing Human Error in the Life Sciences by: Charles H. Paul View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
FDA Regulation of Artificial Intelligence/ Machine Learning by: Edwin Waldbusser View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Excel Basics - Data Visualization - Creating Effective Charts by: Mike Thomas View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Using a Learning Management System (LMS) to Develop Pharma Training Curricula by: Michael Esposito View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements by: John E Lincoln View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 3 Hours Price: $290.00
Introduction to Excel's Built-In Solver - Advanced Decision-Making Tools by: Isaac Gottlieb View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
US, EU, Japan GMP Requirements by: Robert J. Russell View Details Date: 16 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and the Future by: John E Lincoln View Details Date: 17 December, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
FDA Audit Best Practices - Do's and Don'ts by: Charles H. Paul View Details Date: 18 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Excel - Formulas and Functions 101 by: Mike Thomas View Details Date: 18 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
HPLC Analytical Method Development and Validation by: John C. Fetzer View Details Date: 18 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations by: Robert J. Russell View Details Date: 18 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
How to Deal with Bad Results Under GLP by: John C. Fetzer View Details Date: 19 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
Drug Master Files: Understanding and Meeting Your Regulatory and Processing Responsibilities by: Robert J. Russell View Details Date: 19 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats by: Michael Esposito View Details Date: 20 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Price: $150.00
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance by: Edwin Waldbusser View Details Date: 20 December, 2024 Time: 10:00 AM PST | 01:00 PM EST Duration: 60 Minutes Price: $150.00
4-Hour Virtual Seminar on The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and the Future by: John E Lincoln View Details Date: 20 December, 2024 Time: 08:00 AM PST | 11:00 AM EST Duration: 4 Hours Price: $445.00
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity by: David Nettleton View Details Date: 23 January, 2025 Time: 10:00 AM PST | 01:00 PM EST Duration: 75 Minutes Price: $150.00
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations by: Robert J. Russell View Details Recorded View Anytime Price: $390.00
How to Design and Implement Outstanding KPI Performance Dash by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Introduction to Sales and Use Taxation by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Hot Issues in Determining Multi-State Sales Tax Nexus by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Complying with FATCA - the Foreign Accounts Tax Compliance Act by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Compliance and Continual Improvement, Tools of the Trade by: Rodriguez Gonzalez View Details Recorded View Anytime Price: $149.00
Foreign Corrupt Practices Act - Audits Role by: Denise Cicchella View Details Recorded View Anytime Price: $149.00
Operational Risk - Beyond Regulatory Constraints by: Fred Vacelet View Details Recorded View Anytime Price: $149.00
Fundamental ATC Organization, Structure, and Concepts by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
ATC Radar Approach Control (TRACON) by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Mastering the Power of Sensitivity Tools in Financial Modeling by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Air Traffic Control and Airport Operation Coordination by: Roger Nakata View Details Recorded View Anytime Price: $149.00
Project Management - Auditing Problem Projects by: Stuart Gardner View Details Recorded View Anytime Price: $149.00
Understanding Next Gen (FAA New Technology) by: Roger Nakata View Details Recorded View Anytime Price: $149.00
Industrial Technical Benefits- Canada's New Approach to Offsets for Defence Procurement by: Anthony Goode View Details Recorded View Anytime Price: $149.00
Reducing Variation in Manufacturing Processes by: Lynne Hare View Details Recorded View Anytime Price: $149.00
Sanitation Chemical Testing - Best Practices by: Donald Jones View Details Recorded View Anytime Price: $149.00
Nonresident Alien W-8 & 1042-S Compliance Update by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Basics of Compliance for Food Businesses by: Rodriguez Gonzalez View Details Recorded View Anytime Price: $149.00
Planning for Resilience - Best Practices for Developing Reliable Disaster Recovery Plans by: Ms. Michael Redmond View Details Recorded View Anytime Price: $149.00
Airport Traffic Control Tower (ATCT) by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Air Route Traffic Control Center (ARTCC) Operations by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Traffic Flow Management (TFM) Operations-End to End Flight Scenario by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Accounting and Tax Procedures to Maximize your Deductions and Minimize Problems with The IRS by: Reuven Rubinson View Details Recorded View Anytime Price: $149.00
The National Shipbuilding Procurement Strategy- Changing the playing field for shipbuilding in Canada by: Anthony Goode View Details Recorded View Anytime Price: $149.00
The Business of Defence Procurement in Canada- A Market Over by: Anthony Goode View Details Recorded View Anytime Price: $149.00
ISO Standard for Business Continuity (ISO 22301) by: Ms. Michael Redmond View Details Recorded View Anytime Price: $149.00
Using Forensic Accountants Effectively in the Legal Process by: Ray Kulzick View Details Recorded View Anytime Price: $149.00
Detecting Frauds in Purchasing and Payables by: Ray Kulzick View Details Recorded View Anytime Price: $149.00
1099 and W-9 Update - Complying with IRS Information Reporting by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
Controlled Goods in Canada- A primer by: Anthony Goode View Details Recorded View Anytime Price: $149.00
How to Write and Implement Effective Policies & Procedures by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
One practical view of HACCP Plans by: Rodriguez Gonzalez View Details Recorded View Anytime Price: $149.00
Airport Traffic Control Tower (ATCT) by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Air Route Traffic Control Center (ARTCC) Operations by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
Traffic Flow Management (TFM) Operations-End to End Flight Scenario by: Stephen Alvania View Details Recorded View Anytime Price: $149.00
What's Up? (and Down): Outlook for Construction Segments, Materials and Labor by: Kenneth D. Simonson View Details Recorded View Anytime Price: $149.00
Construction Shortages Ahead: Skilled Labor, Skilled Manager by: Kenneth D. Simonson View Details Recorded View Anytime Price: $149.00
How to Analyze Financial Statements by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
The Value of Hourly Cost Maintenance Programs by: Anthony Kioussis View Details Recorded View Anytime Price: $149.00
Canada's Defence Budget Crisis- Impact of recent Defense Budget Cuts on The Canadian Armed Forces- Opportunities for Industry by: Anthony Goode View Details Recorded View Anytime Price: $149.00
Contract Killer Clauses in Construction: And How to Neutralize Them by: Brian Perlberg View Details Recorded View Anytime Price: $149.00
The Master Validation Plan - The Unwritten Requirements by: John E Lincoln View Details Recorded View Anytime Price: $189.00
Quality by Design: Establishing a Systematic Approach to Pharmaceutical development by: Heath Rushing View Details Recorded View Anytime Price: $189.00
FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List by: David R Dills View Details Recorded View Anytime Price: $189.00
FDA Compliant HPLC Qualification and Performance Testing by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $189.00
GMP Perspectives on Working with Contracting Laboratories by: Steven S. Kuwahara View Details Recorded View Anytime Price: $189.00
Cleaning and Sanitation Training for Food Processors by: Melinda Allen View Details Recorded View Anytime Price: $189.00
Auditing Analytical Laboratories for FDA Compliance by: Steven S. Kuwahara View Details Recorded View Anytime Price: $189.00
Compiling the Design History File, and Technical File, Design Dossier by: John E Lincoln View Details Recorded View Anytime Price: $189.00
FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators by: David R Dills View Details Recorded View Anytime Price: $189.00
The European Clinical Trial Directive (EUCTD) by: Robert J. Russell View Details Recorded View Anytime Price: $189.00
Quality by Design (QbD) for Development and Validation of Analytical Methods by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $189.00
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Statistical Concepts of Process Validation by: Dan OLeary View Details Recorded View Anytime Price: $189.00
Change Control - Key to Successful cGMP Compliance by: John E Lincoln View Details Recorded View Anytime Price: $189.00
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Foreign Bodies in Foods - Effective Techniques for Prevention, Control and Detection by: Rotimi Toki View Details Recorded View Anytime Price: $149.00
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IT Auditing - Principles and Practices (2nd Edition) by: Robert E. Davis View Details Recorded View Anytime Price: $149.00
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Confidence-Reliability Calculations and Statistically Valid Sample Sizes by: John N. Zorich View Details Recorded View Anytime Price: $189.00
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CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations by: John E Lincoln View Details Recorded View Anytime Price: $189.00
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DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions by: John E Lincoln View Details Recorded View Anytime Price: $189.00
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Introduction to Sales and Use Taxation by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
1099 and W-9 Update - Complying with IRS Information Reporting by: Miles Hutchinson View Details Recorded View Anytime Price: $149.00
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Product Information in the EU by: Adriaan Fruijtier View Details Recorded View Anytime Price: $121.00
cGMPs in the Quality Control Laboratory by: Jerry Lanese View Details Recorded View Anytime Price: $189.00
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Process Capability Analysis of Extremely Non-Normal Data by: John N. Zorich View Details Recorded View Anytime Price: $189.00
Process Capability Analysis by means of Confidence - Reliability Calculations by: John N. Zorich View Details Recorded View Anytime Price: $136.00
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Foreign Bodies in Foods - Effective Techniques for Prevention, Control and Detection by: Rotimi Toki View Details Recorded View Anytime Price: $149.00
Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal by: Rotimi Toki View Details Recorded View Anytime Price: $189.00
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IFRS 6 Oil, Gas, Mining and other Extractive Industries by: Mike Morley View Details Recorded View Anytime Price: $149.00
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Construction - OSHA Construction Basics, for any Jobsite by: Jason Teliszczak View Details Recorded View Anytime Price: $127.00
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BC ISO 22301: Business Continuity Planning by: Ms. Michael Redmond View Details Recorded View Anytime Price: $149.00
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Contract Killer Clauses in Construction: And How to Neutralize Them by: Brian Perlberg View Details Recorded View Anytime Price: $149.00
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Exporting your Dietary Supplements to Canada by: Karen Friedman View Details Recorded View Anytime Price: $149.00
Facing the challenges of Canadian Consumer Health Product Registration by: Karen Friedman View Details Recorded View Anytime Price: $149.00
Designing Full Cyber Security Incident Response Team (CSIRT) Training Program as well as Table Top and Simulation Testing by: Ms. Michael Redmond View Details Recorded View Anytime Price: $149.00
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Resiliency Individual, Community, Business by: Ms. Michael Redmond View Details Recorded View Anytime Price: $149.00
Statistical Methods for Process Validation by: Heath Rushing View Details Recorded View Anytime Price: $189.00
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Clinical Trials in US, Europe and Canada by: Anne Tomalin View Details Recorded View Anytime Price: $127.00
Conducting Observational Studies in US, Canada and Europe by: Anne Tomalin View Details Recorded View Anytime Price: $126.00
Clinical Trial Applications in Canada, and Comparison to the US and Europe by: Anne Tomalin View Details Recorded View Anytime Price: $127.00
International Regulatory Cooperation Among Agencies by: Anne Tomalin View Details Recorded View Anytime Price: $189.00
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Biocompatibility Testing of Medical Devices in the US and Use of ISO-10993 by: Elisa Harvey View Details Recorded View Anytime Price: $189.00
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Airport Traffic Control Tower (ATCT) by: Stephen Alvania View Details Recorded View Anytime Price: $141.00
Terminal Radar Approach Control (TRACON) by: Stephen Alvania View Details Recorded View Anytime Price: $143.00
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Complaint Handling and Management: From Receipt to Trending by: David R Dills View Details Recorded View Anytime Price: $155.00
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements by: David R Dills View Details Recorded View Anytime Price: $148.00
Bullet Proof 510(k) – Latest FDA Changes to the Process by: David R Dills View Details Recorded View Anytime Price: $158.00
Draft Guidance for Device Industry and FDA - Postmarket Surveillance by: David R Dills View Details Recorded View Anytime Price: $154.00
Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products by: David R Dills View Details Recorded View Anytime Price: $190.00
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Calibration and Qualification in Analytical Laboratories by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $183.00
Postmarketing Vigilance Reporting For Medical Device Manufacturers by: David R Dills View Details Recorded View Anytime Price: $190.00
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Conducting Safety Reviews for Systems, Products, Processes, facilities, and Procedures by: Michael Allocco View Details Recorded View Anytime Price: $132.00
Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors by: Betty Lane View Details Recorded View Anytime Price: $148.00
Effective Root Cause Analysis: The key to an Effective Corrective Actions System by: Betty Lane View Details Recorded View Anytime Price: $147.00
Good Documentation Practices for GxP Compliance by: Alla Teresh View Details Recorded View Anytime Price: $144.00
FDA Export Certificates for Medical Devices by: Larry Spears View Details Recorded View Anytime Price: $146.00
Nonresident Alien W-8 & 1042-S Compliance Update by: Miles Hutchinson View Details Recorded View Anytime Price: $142.00
How to Design and Implement Outstanding KPI Performance Dashboards by: Miles Hutchinson View Details Recorded View Anytime Price: $146.00
Introduction to Sales and Use Taxation by: Miles Hutchinson View Details Recorded View Anytime Price: $145.00
Financial Statement Preparation and Analysis by: Miles Hutchinson View Details Recorded View Anytime Price: $190.00
FDA Regulation of In Vitro Diagnostics by: Thomas E. Colonna View Details Recorded View Anytime Price: $134.00
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FDA Regulation of Dietary Supplements by: Thomas E. Colonna View Details Recorded View Anytime Price: $137.00
Medical Device Registration & Listing, and Inspection Follow-up Activities by: Larry Spears View Details Recorded View Anytime Price: $147.00
Regulation of the Practice of Geology in the United States by: Mark Brengelman View Details Recorded View Anytime Price: $131.00
Medical Device Product Development Process by: Karl Leinsing View Details Recorded View Anytime Price: $147.00
Excel Spreadsheet Validation for FDA 21 CFR Part 11 by: Angela Bazigos View Details Recorded View Anytime Price: $157.00
Stress-Testing for Financial Institutions, Beyond Regulatory Constraints by: Fred Vacelet View Details Recorded View Anytime Price: $140.00
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) by: Angela Bazigos View Details Recorded View Anytime Price: $163.00
FDA's enforcement of 21 CFR part 11 compliance by: Angela Bazigos View Details Recorded View Anytime Price: $167.00
Introduction to Program-Project Management by: Drex Rutledge View Details Recorded View Anytime Price: $124.00
Anti-Money Laundering (AML) -Connecting the Dots by: James Bone View Details Recorded View Anytime Price: $148.00
Why Good Risk Management is so Elusive by: James Bone View Details Recorded View Anytime Price: $152.00
Auditing Enterprise Risk Management by: Denise Cicchella View Details Recorded View Anytime Price: $137.00
Foreign Corrupt Practices Act - Audits Role by: Denise Cicchella View Details Recorded View Anytime Price: $141.00
Meeting Annual U.S. FDA cGMP Training Requirements by: John E Lincoln View Details Recorded View Anytime Price: $162.00
Device Changes, FDA Changes, and the 510(k) by: John E Lincoln View Details Recorded View Anytime Price: $141.00
Product Risk Management - ISO 14971:2007 by: John E Lincoln View Details Recorded View Anytime Price: $137.00
Setting Up and Running a Tougher Supplier Audit Program by: John E Lincoln View Details Recorded View Anytime Price: $190.00
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Electronic Informed Consent for clinical trials: Why, What and How by: Susan Brink View Details Recorded View Anytime Price: $144.00
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Food Import Detections and Seizures: The Current and Future Regulatory Environment by: John Ryan View Details Recorded View Anytime Price: $126.00
Capturing the Most Powerful Market - Moms by: Shari Storm View Details Recorded View Anytime Price: $132.00
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Building a Sustainable Vendor Qualification Program by: Jonathan M. Lewis View Details Recorded View Anytime Price: $158.00
FDA Inspections – Do's and Don'ts by: Jonathan M. Lewis View Details Recorded View Anytime Price: $161.00
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What Contractors Need to Know About AIA A201 and Consensus Docs Contracts by: Brian Perlberg View Details Recorded View Anytime Price: $146.00
Reclaiming Large Excel Spreadsheets by: David Ringstrom View Details Recorded View Anytime Price: $152.00
Spreadsheet-Based Internal Controls by: David Ringstrom View Details Recorded View Anytime Price: $153.00
Sample Size and Statistical Rationale for Medical Device Packaging Validations by: Karen Greene View Details Recorded View Anytime Price: $148.00
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Validation Master Planning and Regulatory Expectations by: Louis Angelucci View Details Recorded View Anytime Price: $157.00
Introduction to Risk Assessment by: Louis Angelucci View Details Recorded View Anytime Price: $145.00
Building Quality Systems for Pharmaceutical and Medical Device Firms by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
Building a Successful Relationship with the US FDA: Key Steps by: Robert Kunka View Details Recorded View Anytime Price: $127.00
The Bayh-Dole Act and Its Implementing Regulations & Rule-Making by: Ronald Kudla View Details Recorded View Anytime Price: $143.00
Risk Management for Commissioning and Qualification for Pharmaceutical Industry by: Majdi Ayoub View Details Recorded View Anytime Price: $151.00
Lean Warehousing: Cutting Waste and Improving Efficiencies with the Proven Principles of Lean Management by: Brad Bossence View Details Recorded View Anytime Price: $153.00
Quality Agreements and Annual Inspections by: Jerry Dalfors View Details Recorded View Anytime Price: $158.00
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Strategic Management of Corporate Governance: Setting the Right Tone at the Top about Risk, Part 1 by: Ron Rael View Details Recorded View Anytime Price: $128.00
Ethical Compliance Starts with Accountability by: Ron Rael View Details Recorded View Anytime Price: $132.00
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Operational Risk for Financial Institutions - Beyond Regulatory Constraints by: Fred Vacelet View Details Recorded View Anytime Price: $143.00
Implementing Value-Based Physician Compensation Models by: Joseph Wolfe View Details Recorded View Anytime Price:
Implementing Value-Based Physician Compensation Models by: Joseph Wolfe View Details Recorded View Anytime Price:
Stark Compliance Audits in Hospital-Physician Arrangements by: Joseph Wolfe View Details Recorded View Anytime Price:
Contract Killer Clauses in Construction: And How to Neutralize Them by: Brian Perlberg View Details Recorded View Anytime Price: $148.00
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From Project Manager to Project Leader by: Heath Suddleson View Details Recorded View Anytime Price: $147.00
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Construction 3.0 Leadership: How to Unleash Your Company's Potential for Greater Profitability by: Ted Garrison View Details Recorded View Anytime Price: $144.00
The New Clinical Trial Regulation by: Adriaan Fruijtier View Details Recorded View Anytime Price: $146.00
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Pediatric Drug Development: Regulatory Expectations with New Laws by: Robert Kunka View Details Recorded View Anytime Price: $190.00
Good Documentation Practices for GxP Compliance by: Alla Teresh View Details Recorded View Anytime Price: $190.00
Analytical Instrument Qualification According The New Revision of USP 1058 by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
FDA's New Enforcement of 21 CFR Part 11 by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
FDA's Bioresearch Monitoring (BIMO) Program Biologic, Device, Animal Drug, and Food Areas by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
FDA Regulation of Combination Products by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
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Verification or Validation of Methods in Food Microbiology by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
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In Other Words- The Clinical and Construction Guide to Building Patient Centered Environments by: Cathy Dolan-Schweitzer View Details Recorded View Anytime Price: $190.00
Development and Implementation of an Internal Auditing Program as part of a Pharmaceutical Manufacturing Quality System by: Joseph Habarta View Details Recorded View Anytime Price: $190.00
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The Bayh-Dole Act and Its Implementing Regulations & Rule-Making by: Ronald Kudla View Details Recorded View Anytime Price: $190.00
FSMA Impact to the Transportation of Perishables by: John Ryan View Details Recorded View Anytime Price: $190.00
USFDA Food Import and Export: Current and Future Safety Regulations by: John Ryan View Details Recorded View Anytime Price: $190.00
Operational Risk - Beyond Regulatory Constraints by: Fred Vacelet View Details Recorded View Anytime Price: $190.00
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Electronic Informed Consent for Clinical Trials: Why, What and How by: Susan Brink View Details Recorded View Anytime Price: $190.00
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PMBA - Project Management Business Administration by: Heath Suddleson View Details Recorded View Anytime Price: $190.00
IFRS 6 for Oil, Gas and Mining Industries by: Mike Morley View Details Recorded View Anytime Price: $190.00
Does Anyone Care About SOX Anymore? by: Mike Morley View Details Recorded View Anytime Price: $190.00
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Corporate Expense Accounts Review and Audit Best Practices by: Mike Morley View Details Recorded View Anytime Price: $190.00
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SOPs for Clinical Trials: Regulatory Requirements by: Harold Thibodeaux View Details Recorded View Anytime Price: $190.00
Sterile Medical Packaging Design - 7 Essentials by: Karen Greene View Details Recorded View Anytime Price: $190.00
Sample Size and Statistical Rationale for Medical Device Packaging Validations by: Karen Greene View Details Recorded View Anytime Price: $190.00
Menu Labelling: Knowing The Requirements and Available Options for Achieving Compliance by: Rotimi Toki View Details Recorded View Anytime Price: $190.00
Combined HACCP Development & Risk- Based HACCP by: Rotimi Toki View Details Recorded View Anytime Price: $190.00
Understanding Autism Spectrum Disorder by: Jd Marhevko View Details Recorded View Anytime Price: $190.00
Post-approval changes for medicinal products in the EU by: Adriaan Fruijtier View Details Recorded View Anytime Price: $190.00
Orphan Medicinal Product Designation in the EU by: Adriaan Fruijtier View Details Recorded View Anytime Price: $190.00
Pediatric Investigation Plans (PIP) in the EU by: Adriaan Fruijtier View Details Recorded View Anytime Price: $190.00
Sanitizers for the Food Industry by: Norman G. Marriott View Details Recorded View Anytime Price: $190.00
The Marriage of the PFMEA and Control Plan, A Dynamic Control Plan by: Jd Marhevko View Details Recorded View Anytime Price: $190.00
Predictive Warranty using Paynter Charts by: Jd Marhevko View Details Recorded View Anytime Price: $190.00
Calibrating the Human Gage: Attribute Agreement Analysis by: Jd Marhevko View Details Recorded View Anytime Price: $190.00
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Introduction to SPC (Statistical Process Control) by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Normality Tests and Normality Transformations: Explanations, Justifications, and Uses by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Metrology: Statistical Analysis of Measurement Uncertainty by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Construction - OSHA Construction Basics, for any Jobsite by: Jason Teliszczak View Details Recorded View Anytime Price: $190.00
Traceability and Recall Through Food Processes by: John Ryan View Details Recorded View Anytime Price: $190.00
Standardizing Transportation Procedures to Control Food Safety and Quality by: John Ryan View Details Recorded View Anytime Price: $190.00
Prepare Your Company to Meet the Final FSMA Subpart G Rule Requirements for the Receiver Liability for Supplier Preventive Controls by: John Ryan View Details Recorded View Anytime Price: $190.00
Validating Radiation Sterilization for Medical Products by: Karl J Hemmerich View Details Recorded View Anytime Price: $190.00
Accelerated Aging Techniques for Medical Device Packaging by: Karl J Hemmerich View Details Recorded View Anytime Price: $190.00
Outlook for Multifamily Housing by: Bernard Markstein View Details Recorded View Anytime Price: $190.00
Reclaiming Large Excel Spreadsheets by: David Ringstrom View Details Recorded View Anytime Price: $190.00
Spreadsheet-Based Internal Controls by: David Ringstrom View Details Recorded View Anytime Price: $190.00
Expedite Excel with Hidden Shortcuts by: David Ringstrom View Details Recorded View Anytime Price: $190.00
Transcend VLOOKUP in Microsoft Excel by: David Ringstrom View Details Recorded View Anytime Price: $190.00
Key Steps to Successful Project Management Principles by: Carol Friedhoff View Details Recorded View Anytime Price: $190.00
The Role of FDA in Health Care Software Regulations and Development by: Anna Longwell View Details Recorded View Anytime Price: $190.00
FDA's Medical Device Clinical Trials Program by: Anna Longwell View Details Recorded View Anytime Price: $190.00
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot by: Anna Longwell View Details Recorded View Anytime Price: $190.00
Clinical Trial Applications in Canada, and Comparison to the US and Europe by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Current Status of biosimilars in US, Europe and Canada by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Food Safety, Security and Fraud-Are You Ready by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
Quality Control for Analytical Materials used in Microbiology Laboratories by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
Understanding the USP Chapter 1224 for Transfer of Analytical Methods by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Effective Training Practices for FDA Compliance by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Managing Client Expectations Without Losing Your Shirt or the Next Job by: Heath Suddleson View Details Recorded View Anytime Price: $190.00
From Project Manager to Project Leader by: Heath Suddleson View Details Recorded View Anytime Price: $190.00
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FDA Regulation of Dietary Supplements by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
Introduction to FDA Regulation of Combination Products by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
Establishment of Quality Systems by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
Introduction to Risk Assessment by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
Validation Master Planning and Regulatory Expectations by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
2011 FDA Guideline on Process Validation by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
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Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA by: James E. Russell View Details Recorded View Anytime Price: $190.00
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
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FDA Regulations for Analytical Instrument Qualification and Validation Processes by: Joy McElroy View Details Recorded View Anytime Price: $190.00
Best Practices for an Effective Cleaning Validation Procedures by: Joy McElroy View Details Recorded View Anytime Price: $190.00
FDA Regulations for Environmental Monitoring(EM) Program by: Joy McElroy View Details Recorded View Anytime Price: $190.00
The New European Clinical Trial Regulation by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration by: Jose Mora View Details Recorded View Anytime Price: $190.00
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration by: Jose Mora View Details Recorded View Anytime Price: $190.00
Research Use Only Products - The Dos and Don'ts by: Harold Thibodeaux View Details Recorded View Anytime Price: $190.00
FDA New Drug Approval Process by: Harold Thibodeaux View Details Recorded View Anytime Price: $190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions by: Robert Michalik View Details Recorded View Anytime Price: $190.00
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Process Capability Analysis by means of Confidence - Reliability Calculations by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Process Capability Analysis of Extremely Non-Normal Data by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Introduction to SPC (Statistical Process Control) by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Modeling and Optimizing Process Behavior using Design of Experiments by: Steven Wachs View Details Recorded View Anytime Price: $190.00
Excel Spreadsheet Validation for FDA 21 CFR Part 11 by: Angela Bazigos View Details Recorded View Anytime Price: $190.00
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs) by: Angela Bazigos View Details Recorded View Anytime Price: $190.00
FDA's 21 CFR 11 Add-On Inspections - Recent Updates by: Angela Bazigos View Details Recorded View Anytime Price: $190.00
Using Statistics to Determine Sample Size by: Steven Walfish View Details Recorded View Anytime Price: $190.00
Sample Size and Statistical Rationale for Medical Device Packaging Validations by: Karen Greene View Details Recorded View Anytime Price: $190.00
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Conducting Observational Studies in US, Canada and Europe by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Clinical Trials in US, Europe and Canada by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Current Status of Biosimilars in US, Europe and Canada by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Carrier Food Safety Problems That May Occur during Transportation (FDA-FSMA) by: John Ryan View Details Recorded View Anytime Price: $190.00
Conducting Successful Product Complaint Investigations by: David R Dills View Details Recorded View Anytime Price: $190.00
Complaint Handling and Management: From Receipt to Trending by: David R Dills View Details Recorded View Anytime Price: $190.00
Construct and Manage the Technical File and Design Dossier by: David R Dills View Details Recorded View Anytime Price: $190.00
The Master Validation Plan - The Unwritten Requirements by: John E Lincoln View Details Recorded View Anytime Price: $190.00
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Device Changes, FDA Changes, and the 510(k) by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Drafting a Software V&V Documentation Package and Protocol by: John E Lincoln View Details Recorded View Anytime Price: $190.00
The Most Common Problems in FDA Software Validation & Verification by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Change Control - The Achilles Heel of cGMP Compliance by: John E Lincoln View Details Recorded View Anytime Price: $190.00
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Combination Products: FDA's Final Rule for GMP Requirements by: David R Dills View Details Recorded View Anytime Price: $190.00
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements by: David R Dills View Details Recorded View Anytime Price: $190.00
Update on Unique Device Identifier for Device Manufacturers by: David R Dills View Details Recorded View Anytime Price: $190.00
Managing Your Medical Device Reporting (MDR) Program for Compliance Success by: David R Dills View Details Recorded View Anytime Price: $190.00
Postmarketing Vigilance Reporting For Medical Device Manufacturers by: David R Dills View Details Recorded View Anytime Price: $190.00
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends by: David R Dills View Details Recorded View Anytime Price: $190.00
Setting the ideal cGMP HVAC Design Requirements for Pharmaceutical Sterile and Sterile Facilities by: Majdi Ayoub View Details Recorded View Anytime Price: $190.00
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot by: Anna Longwell View Details Recorded View Anytime Price: $190.00
FDA's Medical Device Clinical Trials Program by: Anna Longwell View Details Recorded View Anytime Price: $190.00
Managing Your FDA 483 Inspectional Observations by: Casper Uldriks View Details Recorded View Anytime Price: $190.00
Contract Killer Clauses in Construction: And How to Neutralize Them by: Brian Perlberg View Details Recorded View Anytime Price: $190.00
FDA Export Certificates for Medical Devices by: Larry Spears View Details Recorded View Anytime Price: $190.00
SOPs for Clinical Trials: Regulatory Requirements by: Harold Thibodeaux View Details Recorded View Anytime Price: $190.00
Combination Products: A Regulatory Perspective by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
Understanding, Calculating, and Using Statistical Power by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Understanding and Preparing for FDA's on-going Part 11 Inspection Program by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Japan Regulatory Approval Process for BioPharma and Medical Devices by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
Water System Biofilm Control and Microbial Monitoring Myths by: Teri C. Soli View Details Recorded View Anytime Price: $190.00
GMP Expectations for Products Used in Early Phase IND Studies by: Steven S. Kuwahara View Details Recorded View Anytime Price: $190.00
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Understanding the USP Chapter 1224 for Transfer of Analytical Methods by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Valid Statistical Rationales for Sample Sizes by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Good Documentation Practice for GxP Environments by: John R. Godshalk View Details Recorded View Anytime Price: $190.00
Lyophilization: What you Need to Know, Validation and Regulatory Approaches by: John R. Godshalk View Details Recorded View Anytime Price: $190.00
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects by: John R. Godshalk View Details Recorded View Anytime Price: $190.00
Complaint Handling in Compliance with FDA and ISO Regulations by: Jeff Kasoff View Details Recorded View Anytime Price: $190.00
2011 FDA Guideline on Process Validation by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
Validation Master Planning and Regulatory Expectations by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
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HPLC Analytical Method Development and Validation by: John C. Fetzer View Details Recorded View Anytime Price: $190.00
Direct-to-Consumer (DTC) Marketing: Impacts and Policy Implications by: Casper Uldriks View Details Recorded View Anytime Price: $190.00
Secrets to Writing Effective SOPs for Medical Device QMS by: Susanne Manz View Details Recorded View Anytime Price: $190.00
Addressing CAPA within a Device Quality System by: Susanne Manz View Details Recorded View Anytime Price: $190.00
Risk Management Techniques for Medical Devices by: Susanne Manz View Details Recorded View Anytime Price: $190.00
GLPs: How are they Associated with GMPs and SOPs by: Joy McElroy View Details Recorded View Anytime Price: $190.00
Responsibilities of the Carrier Under the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods by: John Ryan View Details Recorded View Anytime Price: $190.00
Laboratory Accreditation: Getting There is Just the Beginning by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
Is it Method Verification or Validation, or Just Semantics by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
Laboratory-Developed Tests: Why does FDA think They Can Regulate Them, and Why Do Others Think They Cannot by: Anna Longwell View Details Recorded View Anytime Price: $190.00
Process Capability Analysis by means of Confidence Reliability Calculations by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Process Capability Analysis Of Extremely Non-normal Data by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Managing Your FDA "483" Inspectional Observations by: Casper Uldriks View Details Recorded View Anytime Price: $190.00
Modeling and Optimizing Process Behavior using Design of Experiments by: Steven Wachs View Details Recorded View Anytime Price: $190.00
FDA Perspective on International Clinical Trials: US, EU and Canada by: Anne Tomalin View Details Recorded View Anytime Price: $190.00
Validating the Sterilization Process for a NEW Medical Device by: Karl Leinsing View Details Recorded View Anytime Price: $190.00
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Mastering Excel: How to Create ad hoc and Date Based Groupings within a PivotTable by: Dennis Taylor View Details Recorded View Anytime Price: $190.00
Why use IRS e-services TIN Matching Program by: Greta Hicks View Details Recorded View Anytime Price: $190.00
Determining Sample Size: How to Ensure You Get the Correct One by: Steven Wachs View Details Recorded View Anytime Price: $190.00
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Using Statistics to Determine Sample Size by: Steven Walfish View Details Recorded View Anytime Price: $190.00
Statistical Power and Sample Size by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Valid Statistical Rationales for Sample Sizes by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Financial Statements: The Four Components by: Greta Hicks View Details Recorded View Anytime Price: $190.00
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration by: Jose Mora View Details Recorded View Anytime Price: $190.00
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration by: Jose Mora View Details Recorded View Anytime Price: $190.00
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Implementing the New FDA Data Integrity Guide by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Understanding and Preparing for FDA's on-going Part 11 Inspections by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Good Laboratory Practice Regulations - Introduction and Strategies for Implementation by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
FDA's 21 CFR 11 Add-On Inspections - Recent Updates by: Angela Bazigos View Details Recorded View Anytime Price: $190.00
FDA's Medical Device Clinical Trials Program by: Anna Longwell View Details Recorded View Anytime Price: $190.00
Applying Statistical Process Control Effectively by: Steven Wachs View Details Recorded View Anytime Price: $190.00
Laboratory Investigation of Out-of-Specification Results by: Jerry Lanese View Details Recorded View Anytime Price: $190.00
USFDA Food Import and Export: Current and Future Safety Regulations by: John Ryan View Details Recorded View Anytime Price: $190.00
Understanding FDA's Quality Metrics Draft Guidance and Its Impact by: Louis Angelucci View Details Recorded View Anytime Price: $190.00
Determining Sample Size: How to Ensure You Get the Correct by: Steven Wachs View Details Recorded View Anytime Price: $190.00
Time-Saving Excel Tips, Tricks and 100 Shortcuts by: Dennis Taylor View Details Recorded View Anytime Price: $190.00
The Bayh-Dole Act and Its Implementing Regulations & Rule-Making by: Ronald Kudla View Details Recorded View Anytime Price: $190.00
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC by: John N. Zorich View Details Recorded View Anytime Price: $190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions by: Robert Michalik View Details Recorded View Anytime Price: $190.00
FDA Issues Final Rule on Symbols in Labeling by: David R Dills View Details Recorded View Anytime Price: $190.00
Understanding, Calculating, and Using Statistical Power by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Valid Statistical Rationales for Sample Sizes by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Process Capability Analysis by means of Confidence Reliability Calculations by: Michael Brodsky View Details Recorded View Anytime Price: $190.00
Introduction to SPC (Statistical Process Control) by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Device Changes, FDA Changes, and the 510(k) by: John E Lincoln View Details Recorded View Anytime Price: $190.00
The Master Validation Plan - The Unwritten Requirements by: John E Lincoln View Details Recorded View Anytime Price: $190.00
Water System Biofilm Control and Microbial Monitoring Myths by: Teri C. Soli View Details Recorded View Anytime Price: $190.00
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences by: Robert J. Russell View Details Recorded View Anytime Price: $190.00
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FDA's New Enforcement of 21 CFR Part 11 by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
FDA - Legal Writing Skills that Result in Effective Regulatory Submissions by: Robert Michalik View Details Recorded View Anytime Price: $190.00
Chemistry 101 for Medical Device Regulatory & Quality Professionals: Essential knowledge needed to Manage Drug&Device Combination Product Project by: Robert Michalik View Details Recorded View Anytime Price: $190.00
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) by: Jose Mora View Details Recorded View Anytime Price: $190.00
Risk Management Utilizing Lean Documents and Lean Configuration by: Jose Mora View Details Recorded View Anytime Price: $190.00
Effective Training Practices for FDA Compliance by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Validation of Analytical Methods and Procedures by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
Understanding and Implementing USP 1058 Analytical Instrument Qualification by: Dr. Ludwig Huber View Details Recorded View Anytime Price: $190.00
FDA Regulation of Dietary Supplements by: Thomas E. Colonna View Details Recorded View Anytime Price: $190.00
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Valid Statistical Rationales for Sample Sizes by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Understanding, Calculating, and Using Statistical Power by: John N. Zorich View Details Recorded View Anytime Price: $190.00
Introduction to SPC (Statistical Process Control) by: John N. Zorich View Details Recorded View Anytime Price: $190.00
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The Role of FDA in Health Care Software Regulations and Development by: Anna Longwell View Details Recorded View Anytime Price: $190.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures by: Edwin Waldbusser View Details Recorded View Anytime Price: $190.00
Software Validation for the New FDA Inspections by: Edwin Waldbusser View Details Recorded View Anytime Price: $190.00