GCP Announces Webinar on Risk Management for Pharmaceutical Change Control program

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

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

Deadline: April 22, 2014 | Date: April 22, 2014

Venue/Country: USA, U.S.A

Updated: 2014-03-11 15:29:48 (GMT+9)

Call For Papers - CFP

Change is inevitable in the pharmaceutical industry. Manufacturing process changes and product changes are common post approval activities. Therefore, managing change is as much a business need as it is a regulatory need for pharmaceutical companies to stay in compliance. It is a process that can significantly impact the efficiency of an organization. This presentation will introduce a risk based approach and procedure with regard to severity, likelihood and detection to manage the change control program.

Why should you attend:

Specifications of pharmaceuticals products are defined based on the identity, strength, quality, purity. Therefore, when changes occur, quality and efficacy of the products would be at risk. Companies must have a good change control program to keep the product in compliance with current regulations.

Areas Covered in the Session:

Identify potential problems

Assess the current state process

Determine likely causes

Define the desired future state process

System validation

Plan training and implementation

Monitor continuous improvement and support

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.

Quick Contact:

GlobalCompliancePanel

USA Phone:800-447-9407

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1dS4Zan