GMP Requirements for Validation and Re-Validation of Analytical Procedures
Instructor:
Kim Huynh-Ba
Product ID: 703041
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
New medicines are developed every day to meet medical needs and improve quality of life. Analytical procedures are used to establish acceptance criteria and monitor quality of drug products. Therefore, validation becomes a critical process especially with the changes throughout the drug development process. It is important to understand validation requirements set forth by ICH and GMPs.
This webinar will present the common deficiencies in relation to method validation, outline regulatory requirements and the change control process needed to stay in compliance.
Learning Objectives:
Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It will help scientists develop process for evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.
Areas Covered in the Webinar:
- Deficiencies related to method validation
- Factors affecting quality of medicines
- Validation characteristics
- Validation vs re-validation plan
- Tracking record of validation project
- Change control of validation
Who will Benefit:
- Senior management in pharmaceutical analysis
- Pharmaceutical scientists
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs personnel
- Contract research laboratory personnel
Kim Huynh-Ba
Founder and Technical Director, Pharmalytik
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is 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. Prior to this position, she was the director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analyses and analytical chemistry graduate courses.
Ms. Huynh-Ba serves on the executive committee of the governing board of Eastern Analytical Symposium (EAS) and will be their president for 2013. She is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.
Ms. Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and globally, in the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).
More Training By Experts
- Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to Meet ICH Requirements
- Stability Program to Support Shipping and Distribution of Drug Products
- To Validate or Not To Validate: A Daily Question for the Pharmaceutical Scientist
- Establish Change Control for Pharmaceutical Stability Program
- Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
