Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.
Why should you attend: FDA and regulatory agencies are looking closely in how pharmaceutical companies conduct their investigations, and CAPA is viewed as the central component of Quality Management Systems. However, a significant number of FDA_483 observations and Warning Letters cite CAPA deficiencies. This session will cover regulatory requirement for a CAPA system.
Areas Covered in the Session:
- Why an effective CAPA system is important
- Roles and responsibilities of manufacturers
- Identifying sources of infractions
- Determining root causes
- CAPA Tracking System and documentation
Who Will Benefit:
- Laboratory Analysts
- Quality Assurance scientists
- QA/QC Analysts
- QA/QC Managers
- Pharmaceutical development and manufacturing personnel
- Manufacturers of raw materials and excipients
- Contract laboratory Organization personnel
Don't wait to register for the Webinar on Developing an Effective CAPA Program for GMP Operations. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.
|Conference/Event Dates:||10/12/2015 - 10/12/2015|
|Other Industries:||Pharmaceutical, Professional Healthcare|
|Cost to Attend:||http://bit.ly/1HZhrCU|
Quality Assurance scientists
Pharmaceutical development and manufacturing personnel
Manufacturers of raw materials and excipients
Contract laboratory Organization personnel
|Sponsorship Details:||NetZealous LLC DBA Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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Speaker ProfileKim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently 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 since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines.
Kim 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 (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.
Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. Kim currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. Kim 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.
Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of 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.