EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Water System Mythology: Common False Beliefs for Microbial Control and Monitoring
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Data Integrity and Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.
Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Sample Size Determination for Design Validation Activities
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Expedite Excel with Hidden Shortcuts
Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.
Speaker: David Ringstrom | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
How to write SOP's that Avoid Human Error
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Preventing Human Error in the Life Sciences
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on CAPA for Medical Devices
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources.
Speaker: Susanne Manz | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Sample Size Determination for Design Validation Activities
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Risk Management - Implementing ISO14971: 2019
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Computer System Validation (CSV) for FDA-Regulated Computers
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
Creating Optimal Sampling Plans
A sampling plan is a term widely used in research studies that provide an outline on the basis which of research is conducted. It tells which category is to be surveyed, what should be the sample size and how the respondents should be chosen out of the population.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Handling OOS Test Results and Completing Robust Investigations
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Medical Device Risk Management following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post production risk management program be implemented.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
HPLC Analytical Method Development and Validation
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Analytical Method Validation Under Good Laboratory Practices - GLPs
If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.
Speaker: John C. Fetzer | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Sample Size Determination for Design Validation Activities
Design Validation should ensure that product performance, quality, and reliability requirements are met.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Useful Statistical Methods for Defining Product and Process Specifications
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
Speaker: Steven Wachs | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Using Statistics to Determine Sample Size
We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners.
Speaker: Steven Wachs | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Dietary Supplements CGMPS - 21 CFR 111 Compliance
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Risk Management - Implementing ISO14971: 2019
Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.
Speaker: Yuval Shapiro | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation Files - The US FDA and EU MDR Requirements
It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Project Management for FDA-Regulated Companies
This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the activity over time.
Speaker: John E Lincoln | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products.
Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The 7 Habits of Highly Effective Project Managers
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's Cloud Compliance & Regulations
This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).
Speaker: Eyal Lerner | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA Regulation of Dietary Supplements
FDA regulates both finished dietary supplement products and dietary ingredients.
Speaker: Thomas E. Colonna | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Computer System Validation (CSV) for FDA-Regulated Computers
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Good Documentation Practices to Support FDA Computer System Validation
As a "GxP"system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA's New Import Program for 2020 and Impact of the COVID-19
In this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions.
Speaker: Michael Esposito | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
2- Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry
Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform.
Speaker: Michael Esposito | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
3-Hour Virtual Seminar on What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
It has often been stated that "FDA inspects for compliance; European inspectors inspect for adequate science".
Speaker: Angela Bazigos | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Human error is known to be the major cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities,which in turn generate many types of electronic records.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Metrology: Statistical Analysis of Measurement Uncertainty
The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
The 7 Habits of Highly Effective Project Managers
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence.
Speaker: Steve Gompertz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments
Human error is known to be the primary cause of quality and production losses in many industries.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Time-Saving Excel Tips, Tricks and 100 Shortcuts
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail:
Speaker: Dennis Taylor | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
FDA Audit Best Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.
Speaker: Charles H. Paul | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Responsibility for Off-label Claims in Social Media
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
FDA's New Import Program for 2020
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.
Speaker: John E Lincoln | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Computer System Validation (CSV) for FDA-Regulated Computers
The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.
Speaker: Teri C. Soli | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.
Speaker: John N. Zorich | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Software Validation for the New FDA Inspections
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Determining Sample Size: What Sample Size Should I Use?
The webinar will provide important considerations when selecting sample sizes for specific applications.
Speaker: Steven Wachs | View Anytime | Duration: 75 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion
FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 2 Hours | Price: ¤240.00 | View Details
Valid Statistical Rationales for Sample Sizes
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
Speaker: John N. Zorich | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
FDA's New Draft Guidance on Software and Device Changes and the 510(k)
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required.
Speaker: Carolyn Troiano | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.
Speaker: Ginette Collazo | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Death By CAPA - Does your CAPA Program Need a CAPA?
This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Quality is not an Organization
What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Software Validation for the New FDA Inspections
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Latin America Regulatory Compliance: Current Challenges in Argentina, Brazil and Mexico
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes.
Speaker: Susanne Manz | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Fishbone Diagramming
Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability.
Speaker: Michael Abitz | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details
If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Audit Trail Generation and Review
This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
3-Hour Virtual Seminar on Human Error Reduction in GMP Related Environments
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.
Speaker: Ginette Collazo | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View Details
Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.
Speaker: Angela Bazigos | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View Details
Excel Formulas and Functions
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.
Speaker: Dennis Taylor | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View Details