Application of Validation Principles to the Training Quality System Part 4 – Training Recipients (Trainees)

Adult education of employees in the pharmaceutical industry is often not effective. Insufficient effort regarding trainees is part of this problem. Selection of trainees without regard for pre-requisite competencies, skills, and attitudes of trainees is usually not done. Post-training follow-up on trained trainees to determine training success and to indicate possible improvements in training content, delivery, or emphasis is also overlooked. Applying validation approaches will address these deficiencies and ultimately strengthen the site training quality system.INTRODUCTIONThis paper continues...

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Training. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

Analytical Method Validation for Biopharmaceuticals, Part 2

The  FDA Guidances for Industry states that results from robustness studies should be provided, along with the method validation results, upon submission of the Biologics License Application (BLA) (17,54). However, the guidance also advises that the evaluation of method robustness may be conducted as part of method development or it may be performed as part of a planned method validation study. Therefore, it is up to each method developer to justify the robustness data of the method being submitted for consideration, using data from either method development and/or from a planned robustness study conducted as part of method validation. 

This content is only available to IVT members.
Get help maintaining your knowledge in Method Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Validation Documents Forum No. 1: An Expanded Focus on Validation Documents Invitation to Participate

This feature provides a forum for validation managers and associated personnel to share information about documents associated with the validation function.  

This content is only available to IVT members.
Get help maintaining your knowledge in Documentation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Statistics in Validation

If you are looking for a comprehensive overview of fundamentals regarding statistics in validation, this IVT Network Special Edition is perfect for you. Statistics in Validation is a compilation of 13 of our most robust peer reviewed papers by some of the most reknown validation statisticians, to help you uncover best practices for your experiments.
In this Edition, you will take a deep dive into proceess validation with a statistical viewpoint, explore design of experiemnts (DOE), and read about illumninating case studies from industry experts. Such authors include award-winning Kevin O'Donnell from the European Medicines Agency, and one of IVT's most-read authors, Eugenie Khlebnikova of McNeil Consumer Healthcare.

A complete overview is below.

Table of Contents

Risk Analysis and Design of Experiments in Process Validation Stage 1
Kevin O'Donnell

First Steps in Experimental Design II: More on Screening Experiments
John A. Wass

A Further Step in Experimental Design (III): The Response Surface
John A. Wass

Linear Regression 101
Yanhui Hu

Linear Regression 102: Stability Shelf Life Estimation Using Analysis of Covariance
David LeBlond, Daniel Griffith, and Kelly Aubuchon

Understanding and Reducing Analytical Error—Why Good Science Requires Operational Excellence
John McConnell, Brian K. Nunnally, and Bernard McGarvey

Analysis and Control of Variation: Using Process Control to Reduce Variability: Comparison of Engineering Process Control with Statistical Process Control
John McConnell, Brian K. Nunnally, and Bernard McGarvey

Improvement Alphabet: QbD, PAT, LSS, DOE, SPC - How do They Fit Together?
Ronald D. Snee

Statistical Analysis in Analytical Method Validation
Eugenie Webster (Khlebnikova)

Statistical Tools for Development and Control of Pharmaceutical Process: Statistics in the FDA Process Validation Guidance
Paul L. Pluta

Statistical Considerations for Design and Analysis of Bridging Studies
Harry Yang and Timothy Shofield

FDA, Globalization, and Statistical Process Validation
Robert L. Creighton and Marlene Garcia Swider

Statistical Sampling Plan for Design Verification and Validation of Medical Devices
Liem Ferryanto

This content is only available to IVT members.
Get help maintaining your knowledge in Method Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Aligning With the New Guidance: FDA Analytical Procedures and Method Validation

The recent FDA guidance document on analytical methods and validation is discussed. Key points in specific sections including Analytical Methods Development, Content of Analytical Procedures, Analytical Method Validation, Lifecycle Management of Analytical Procedures, and FDA Methods Verification are described. In order to assess company compliance with the new FDA guidance, a gap assessment tool should be created including guidance sections, requirements, remediation activity, and associated requirements. 

This content is only available to IVT members.
Get help maintaining your knowledge in Regulation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Approaching Microbiological Method Validation

Peer Reviewed: Microbiology


Introduction




Mastering Regulatory Compliance: Cybersecurity and Green / Lean Validation Strategies

Peer Reviewed: Green Validation




Quality-by-Design for Analytical Procedures: Decision Rules

Peer Reviewed: Method Validation




USP Expert Panel Responses to Questions and Comments from IVT

IVT Comments on the Stimuli ArticleAt IVT’s Lab Compliance Week conference, held in Philadelphia from December 3–5, 2013, a session was held to discuss the USP stimuli article Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. The following questions and comments were collected and submitted to the USP Expert Panel on Method Validation and Verification. The questions and the Expert Panel responses follow.Questions and ResponsesThe following is a list of the comments and questions. The responses from...

This content is only available to IVT members.
Get help maintaining your knowledge in GXP. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.