Analytical Method Validation for Pharmaceutical, Biopharmaceutical, and Biologics Quality Control

This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of analytical methods for the quality control of small molecule pharmaceuticals, biopharmaceuticals, and biologics. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find method validation among their responsibilities.

Learning Objectives

Upon completion of this course you will have a clear understanding of regulatory agency expectations and will have gained the background knowledge necessary to effectively plan assay validation programs. You will have gained expertise in writing protocols and reports and in setting acceptance limits for assay validation. You will have acquired insight into how to avoid common validation pitfalls and be able to quickly discriminate compliant from non-compliant validation activities. In addition, you will gain practical experience, during a validation workshop, in applying what you have learned.

Course Description

This course provides comprehensive and up-to-date knowledge of assay validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics. The course covers regulatory expectations regarding validation as contained in U.S. and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant method validation plans. There will be an opportunity to apply what you have learned in a validation workshop.

In addition, there will be ample time to address specific problems and questions of individual participants.

Additional benefits of this class include:

• All participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more.
• Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their top method validation challenges, problems, and issues for classroom discussion
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 15 years of industry experience, over 8 years of consulting experience, and over 10 years of experience directing training courses.

________________________________________

COURSE AGENDA

DAY ONE

Session 1

• Introduction
• What are your top validation questions, problems, and issues?
• The Philosophy of Validation or “How to Know if You’re Really Doing Validation”
• U.S. and International Regulations Pertaining to Validation

Session 2

• Key FDA and International Guidance Documents
• Validation Terminology and Definitions
• Validation Methodology
• Special Considerations for Intermediate Precision and Reproducibility

Session 3

• Essential pre-Validation Activities
• Reference Materials

Session 4

• Study Design and Acceptance Limits
• Validation Protocols and Reports
• Revalidation

DAY TWO

Session 1

• Detailed discussion of participant questions, problems, and issues
• Special Validation Topics
• Special Considerations and Advice for Validating Intermediate Precision and Reproducibility
• Validation During Development
• Validating Process Validation Assays
• Validating Cleaning Validation Assays
• Validation Requirements for Compendial Methods
• Validation/Qualification of Lab Equipment
• 21 CFR Part 11 and Validation Data

Session 2

• When Things Go Wrong
• Avoiding Common Validation Pitfalls
• Handling OOS Results
• Review of Recent Validation Related 483s and Warning Letters
• Preparing for FDA Inspection of Your Assay Validation Program

Session 3

• Validation Workshop. Participants will have the opportunity to create and critique validation plans for one or more method types of their choosing

Session 4

• Shortcuts for Keeping Your Validation Knowledge Up To Date
• Question and Answer Session
• Course Wrap-up and Conclusions