FDA’s Final Guidance On Method Development And Validation – What You Must Know

Teachers
Thomas Pritchett
Category:
On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Analytical method validation is crucial for product approval.  Robust methods have always been the foundation of validation, which is further underscored by FDA’s new final guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” released in July of 2016.

Are you prepared to submit your analytical procedure and methods validation data in accordance with new FDA recommendations?  Do you know what you need to do in order to prepare, assemble, and present information in a manner that thoroughly supports your analytical methodologies?

While ICH Q2 (R1) remains the primary Guidance for Method Validation, this information-packed new Final Guidance document details exactly what your submission must have.

LEARNING OBJECTIVES

At the conclusion of this 90-minute session, participants will be able to:

  1. What FDA expects to see in every method procedure you submit
  2. The reference standards and other reference materials FDA expects you to have
  3. FDA expectations for verification of compendial methods
  4. FDA expectations for validation of stability-indicating methods
  5. FDA’s expectations for life cycle management of analytical procedures

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to QA and QC professionals, analytical development and other R&D scientists and project managers, compliance and validation group scientists and managers, regulatory affairs professionals, and anyone involved in the analytical method side of regulatory compliance and QA/QC throughout the product lifecycle. In addition, this course is extremely useful for scientists and other professionals working for contract organizations in a pharmaceutical/biopharmaceutical setting.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Thomas Pritchett
Ph.D. biochemist with over 25 years’ industrial experience in methods development, quality assurance/quality control and CGMP compliance.

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