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Building a Compliant Training Program for GMP, GCP, and Quality Systems
by: Charles H. Paul -
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Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
by: David Nettleton -
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GMP Compliance for Biopharmaceuticals and Cell & Gene Therapy Products
by: Charles H. Paul
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TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
by: Miles Hutchinson -
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Planning for Resilience - Best Practices for Developing Reliable Disaster Recovery Plans
by: Ms. Michael Redmond -
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Traffic Flow Management (TFM) Operations-End to End Flight Scenario
by: Stephen Alvania -
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Traffic Flow Management (TFM) Operations-End to End Flight Scenario
by: Stephen Alvania -
What's Up? (and Down): Outlook for Construction Segments, Materials and Labor
by: Kenneth D. Simonson -
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Quality by Design (QbD) for Development and Validation of Analytical Methods
by: Dr. Ludwig Huber -
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What's Up? (and Down): Outlook for Construction Segments, Materials and Labor
by: Kenneth D. Simonson -
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Construction is Building, but Where will the Workers Come From?
by: Kenneth D. Simonson -
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How to Design and Implement Outstanding KPI Performance Dashboards
by: Miles Hutchinson -
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Traffic Flow Management (TFM) Operations-End to End Flight Scenario
by: Stephen Alvania -
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TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
by: Miles Hutchinson -
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Regulatory Aspects of Advanced Therapy Medicinal Products in the EU
by: Adriaan Fruijtier -
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How to Design and Implement Outstanding KPI Performance Dashboards
by: Miles Hutchinson -
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Building Quality Systems for Pharmaceutical and Medical Device Firms
by: Louis Angelucci -
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Managing Client Expectations Without Losing Your Shirt or the Next Job
by: Heath Suddleson -
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Analytical Instrument Qualification According The New Revision of USP 1058
by: Dr. Ludwig Huber -
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In Other Words- The Clinical and Construction Guide to Building Patient Centered Environments
by: Cathy Dolan-Schweitzer -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Managing Client Expectations Without Losing Your Shirt or the Next Job
by: Heath Suddleson -
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Understanding and Preparing for FDA's on-going Part 11 Inspection Program
by: Dr. Ludwig Huber -
Japan Regulatory Approval Process for BioPharma and Medical Devices
by: Robert J. Russell -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Lyophilization: What you Need to Know, Validation and Regulatory Approaches
by: John R. Godshalk -
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
by: John R. Godshalk -
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Understanding and Preparing for FDA's on-going Part 11 Inspections
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding and Implementing USP 1058 Analytical Instrument Qualification
by: Dr. Ludwig Huber -
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Validation and Control of Excel Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
New FDA or EMA and USP Guidelines for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Understanding the New USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Understanding and Implementing USP 1058 Analytical Instrument Qualification
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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FDA's New Draft Guidance on Software and Device Changes and the 510(k)
by: Carolyn Troiano -
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Managing Client Expectations Without Losing your Shirt or the Next Job
by: Heath Suddleson -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding and Implementing USP 1058 Analytical Instrument Qualification
by: Dr. Ludwig Huber -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
New FDA, EMA and USP Guidelines for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Good Documentation Practices to Support FDA Computer System Validation
by: Carolyn Troiano -
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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3-hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Understanding and Implementing USP 1058 Analytical Instrument Qualification
by: Dr. Ludwig Huber -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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FDA's New Draft Guidance on Software and Device Changes and the 510(k)
by: Carolyn Troiano -
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Good Documentation and Record Keeping Best Practices (FDA & EMA)
by: Dr. Afsaneh Motamed Khorasani -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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MDSAP - How to Implement MDSAP-Requirements into your ISO 13485 Quality Management System?
by: Prof. Dr. h.c. Frank Stein -
ISO 62304 How to Create a Medical Software Development File?
by: Prof. Dr. h.c. Frank Stein -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again
by: Michael Brodsky -
Auditing Laboratories Conducting Assays Supporting Biologics
by: Gwendolyn Wise-Blackman -
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Good Documentation and Record Keeping Best Practices (FDA & EMA)
by: Dr. Afsaneh Motamed Khorasani -
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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
by: Dr. Ludwig Huber -
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Understanding the USP Chapter 1224 for Transfer of Analytical Methods
by: Dr. Ludwig Huber -
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Good Documentation and Record Keeping Best Practices (FDA & EMA)
by: Dr. Afsaneh Motamed Khorasani -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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FDA's New Draft Guidance on Software and Device Changes and the 510(k)
by: Carolyn Troiano -
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Good Documentation Practices to Support FDA Computer System Validation
by: Carolyn Troiano -
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Mobile Medical Apps(is it a FDA Regulated Device) and Cybersecurity
by: Edwin Waldbusser -
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Onboarding is NOT Orientation - How to Improve the New Employee Experience
by: Michael D. Haberman -
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Updated: Employers Playbook for the Families First Coronavirus Act
by: Brenda Neckvatal -
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Corona Virus 2020 Payroll Update: What the Payroll Department Must Know
by: Vicki M. Lambert -
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Drug Master Files: Understanding and Meeting your Regulatory Responsibilities
by: Robert J. Russell -
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Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
by: Edwin Waldbusser -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Data Integrity and Governance for Computer Systems Regulated by FDA
by: Carolyn Troiano -
3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
by: Martin K. Behr, III -
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Auditing Laboratories Conducting Assays Supporting Biologics
by: Gwendolyn Wise-Blackman -
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6-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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How to Prepare for and Host an FDA Inspection and respond to 483's
by: Edwin Waldbusser -
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6-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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6-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Auditing Laboratories Conducting Assays Supporting Biologics
by: Gwendolyn Wise-Blackman -
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3-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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How to Prepare for and Host an FDA Inspection and respond to 483's
by: Edwin Waldbusser -
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ISO-IEC 17025:2017 Update Introduction: Everything Old is New Again
by: Michael Brodsky -
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6-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Project Management for Non-Project Managers - Scheduling your Project
by: Charles H. Paul -
4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
by: Martin K. Behr, III -
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4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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How to Prepare for and Host an FDA Inspection and respond to 483's
by: Edwin Waldbusser -
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4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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3-Hour Virtual Seminar on Harmonized Tariff Schedule Classification
by: Martin K. Behr, III -
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Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
by: Edwin Waldbusser -
4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Project Management for Non-Project Managers - Scheduling your Project
by: Charles H. Paul -
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4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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Project Management for Non-Project Managers - Scheduling your Project
by: Charles H. Paul -
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Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
by: Carolyn Troiano -
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Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
by: Edwin Waldbusser -
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Project Management for Non-Project Managers - Scheduling your Project
by: Charles H. Paul -
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How to Prepare for and host an FDA Inspection and respond to 483's
by: Edwin Waldbusser -
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Project Management for Non-Project Managers - Scheduling your Project
by: Charles H. Paul -
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4-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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6-Hour Virtual Seminar on Project Management for Non-Project Managers
by: Charles H. Paul -
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