ANDAs: FDA Guidance on Stability Testing of Generic Products

Teachers
Kim Huynh-Ba
Category:
Manufacturing/ On Demand Courses/ Regulatory & Compliance/
Clear
Duration: 90 Minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

In September 2012, the new ANDA stability guideline established the regulatory requirements for submitting an abbreviated NDA based on ICH requirements; Due to numerous questions regarding what specific stability data should be included in each ANDA submission, the Office of Generic Drugs (OGD) recently published an addendum.

As this addendum clarifies many of these requirements, an improved understanding of what items it outlines will help your team determine the key steps you need to take.  This 90-minute session will introduce the development of the ICH Q1A(R2) stability guideline and how it leads to the FDA ANDA guideline. It will discuss the key factors of the new FDA stability requirements and how it may impact the analytical development sector of the generic industry.

LEARNING OBJECTIVES

By attending this course, you will learn:

  • The role of stability programs in the drug development process
  • What factors affect the stability profile of drug products
  • Key information that makes the development of generics different than those work with innovator products
  • The impact of the new FDA guideline to Generic Stability Program
  • An overview of ICH Q1A (R2), Q1B, Q1C, Q1D, Q1E
  • How to suggest a Global Stability Protocol for registration

Who Should Attend

WHO SHOULD ATTEND

This course will benefit Scientists, R&D and QC analysts, laboratory managers, directors, regulators, and researchers who are responsible of setting up stability program of pharmaceutical products. In addition, this course is extremely useful for both sponsor and CROs (e.g. Contract Research Organizations) who need an understanding of Stability Requirements.

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

Kim Huynh-Ba
25 years’ in analytical development, project management, strategic drug development and stability sciences.

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