GCP Announces Webinar on Developing an Effective CAPA Program for GMP Operations

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

Category Webinar, Health, Medical, Pharma, Clinical, Food / Drugs

Deadline: April 15, 2014 | Date: April 15, 2014

Venue/Country: USA, U.S.A

Updated: 2014-03-11 15:13:14 (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

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.

Quick Contact:

GlobalCompliancePanel

USA Phone:800-447-9407

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1fBhRYb