Establish an Effective Change Management Process for Stability Studies

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

Why Should You Attend:

Stability is defined as a critical quality attribute (CQA) in the drug development process as it determines the shelf life of a pharmaceutical product; however, change is an inherent part of the product life cycle. Change can be made as an addition, deletion or modification of process, materials, product, procedures, equipment, and these changes may result to adding, canceling, amending or modifying current stability studies. Therefore, an effective change management process is necessary to monitor the stability profile of the product. This session will review the current regulatory requirements such as FDA, ICH, GMP regulations on change control program, discuss a systematic process to evaluate these changes and the types of changes may affect stability studies.

Who Will Benefit:

• Quality control managers and personnel
• Pharmaceutical scientists
• Manufacturers of raw material and ingredients
• QC analysts and lab managers
• QA managers and personnel
• Regulatory affairs professional
• Compliance scientists

Instructor Profile: 

Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is currently the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. In 2011-2013, she took a sabbatical from Pharmalytik to join the USP Convention as the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide. 

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/establish-an-effective-change-management-process-for-stability-studies-webinar-training-704085-prdw?channel=sciencedz