Stability Programs – Key Factors in Meeting FDA/ICH Expectations

Teachers
Judy Carmody
Category:
Regulatory & Compliance/Research & Development/On Demand Courses/
Clear
Duration: 90 Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Stability testing is mandatory as part of cGMP to demonstrate a pharmaceutical product meets its acceptance criteria throughout its shelf life.  A sustainable stability program in compliance with current regulations is therefore critical to development of new pharmaceutical products.  ICH Guideline Q1A (R2) contains harmonized expectations for global stability submission.  Although sometimes confusing and contradictory, FDA and ICH mandates must be considered in tandem to gain market approval

The objective of this interactive 90-minutes online course is to provide you with an overview to establish an effective and compliant stability program for pharmaceuticals and biopharmaceuticals.  Discussion will include a thorough review of US FDA cGMP regulations/ICH Stability guidelines, development stability testing protocol supporting global markets, and strategies to minimize redundant testing for resource saving.

LEARNING OBJECTIVES

By attending this course, you will learn:

  • How to interpret FDA cGMP regulatory requirements for stability testing
  • The role of the Stability Program during the drug development process
  • Essential activities for Drug Product and Drug Substance/API stability programs
  • Impact and proper use of ICH Guidelines in Stability Programs
  • How to review FDA Warning Letters and 483s to enhance and maintain compliance
  • How to keep your stability knowledge up to date

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to methods development scientists and project managers, Stability Group scientists and managers, QC analysts, laboratory managers, validation specialists, QA managers and staff, and anyone involved with regulatory affairs and GMP Laboratory Control Systems compliance. In addition, this course is extremely useful for both sponsor and CROs (e.g. Contract Research)

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

Judy Carmody
Expertise driving vision in operations, QA, control, systems, and validation/analytical development within global organizations.

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