Webinar on Developing an Effective CAPA Program for GMP Operations

Website http://bit.ly/1POPHYi | Edit Freely

Category CAPA Programs for the Medical Device Industry;CAPA Program for GMP Operations webinar;GMP Training

Deadline: October 11, 2015 | Date: October 12, 2015

Venue/Country: Fremont, U.S.A

Updated: 2015-09-22 14:28:06 (GMT+9)

Call For Papers - CFP

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.

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,

161 Mission Falls Lane, Suite 216,

Fremont, CA 94539, USA.

Phone: +1-800-447-9407

Email: supportcompliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/1POPHYi