Stability is a critical quality attribute of pharmaceutical products. Stability program is necessary beyond registration to continue to support marketed products after product launch. It is challenging to design and implement an effective stability program to provide consistencies and effectively evaluate control strategies to maintain the product quality.

This comprehensive live training webinar will discuss specific activities to support the stability program, maintain consistency, support changes, provide data for product investigations and how continue to improve the process throughout the lifecycle of the product. We will also discuss deficiencies for compliance violations of marketed products and latest FDA, ICH and WHO regulatory requirements.

Learning Benefits:

• Understand the role of the stability program supporting marketed products.
• Understand the latest FDA, ICH and WHO regulatory requirements.
• Develop standard stability protocols to provide consistency.
• Develop product understanding to manage changes.
• Establish control strategies to support manufacturing and distribution.
• Analytical procedures considerations to maintain efficiencies.
• Review deficiencies in the stability program and sustain global compliance.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understand the role of the stability program supporting marketed products,
Develop standard stability protocols to provide consistency,
Lifecycle approach for method validation,
Develop product understanding to manage changes,

11:30 AM 10 Minute Break

                Understand specificity requirements based on Q2A&B,
Establish control strategies to support manufacturing and distribution,
Analytical procedures considerations to maintain efficiencies,
Review deficiencies in the stability program and sustain global compliance,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Control
• Quality Assurance
• Analysts and Laboratory Managers
• Regulatory Affairs Professionals
• Pharmaceutical Scientists
• Compliance Scientists
• Manufacturers of raw material and ingredients

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.