Stability is a Critical Quality Attribute, and stability program plays an important role in the Drug Development Process. It is necessary to determine the storage condition and expiry of pharmaceutical products. Several international guidelines have been issued for stability program and companies must adhere to these requirements to gain market access to these countries. These requirements can be quite different such that conducting stability studies require significant resources commitment during development through commercialization. Therefore, maintaining a stability program in compliant state can be challenging and costly. This is essential to many companies with limited resources to focus on key components of stability studies and design the program accordingly.

This live and interactive session will focus on key issues to keep the stability program in compliance. It will review global stability guidelines Q1A(R2), discuss climatic zones and stability requirements of non-ICH countries.

Learning Benefits:

• Stability Requirements in the drug development process.
• Factor that affects stability profile of drug products.
• WHO Stability program requirements.
• Requirements in batch selection and container-closure system.
• Understand Significant Change of ASEAN guidelines.
• Stability protocol and study set up.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Stability requirements from FDA and ICH,
Factors impacting expiration dating,
Discuss Q1B photostability requirement,
Batch selection and container-closure system,

11:30 AM 10 Minute Break

                Discuss climatic zones and global markets,
Understand WHO and ASEAN guidelines,
Stress studies to support shipping and distribution,
Optimizing stability operation,

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

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.