Date: | October 12, 2015 - 10:00am - 11:00am |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | 161 Mission Falls Lane, Suite 216, Fremont, CA, 94539, United States, NetZealous - Compliance4All |
Website for Event: | http://bit.ly/1POPHYi |
Topic: | Personal Trainers and Personal Training |
Description: | Overview: 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 Who Will Benefit: Laboratory Analysts Speaker Profile: Kim 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. Contact Detail: NetZealous - Compliance4All, |
Contact Name: | Event Manager |
Contact Email: | support@compliance4All.com |
Contact Phone: | 18004479407 |