Webinar on Developing an Effective CAPA Program for GMP Operations

Event Details

Time: October 12, 2015 from 10am to 11am
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://bit.ly/1POPHYi
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Sep 18, 2015

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Event Description

Overview:

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
Auditors
Inspectors
Pharmaceutical development and manufacturing personnel
Manufacturers of raw materials and excipients
Contract laboratory Organization personnel

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.

Contact Detail:

NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/1POPHYi