Risk Management for Pharmaceutical Change Control Program

Compliance4All announces webinar on the topic, “Risk Management for Pharmaceutical Change Control Program” on September 16. This webinar will describe the core aspects of change control in the pharmaceutical industry.

Fremont, CA: Compliance4All, a provider of cost-effective regulatory compliance trainings for a wide range of regulated industries, will organize a webinar on September 16. The topic of this webinar is “Risk Management for Pharmaceutical Change Control Program”, and the speaker is Kim Huynh-BA, Executive Director of Pharmalytik.

About the webinar:

Manufacturing process changes and product changes are common post approval activities in the pharmaceutical industry. Therefore, managing change is of importance to a pharmaceutical organization from both the business and regulatory perspectives for it to ensure compliance.

For more information or to register for the webinar, please click here.

Change can significantly impact the efficiency of an organization’s product. This webinar will introduce a risk based approach and procedure with regard to severity, likelihood and detection in managing the change control program.

Specifications of pharmaceutical products are defined based on the identity, strength, quality, and 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.

The speaker will cover all the important aspects of change control. She will cover areas relating to identifying potential problems, assessing the current state process, determining the likely causes of change, defining the desired future state process, system validation, planning training and implementation and monitoring of continuous improvement and support.

About the Speaker:

Kim Huynh-BA is 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.

She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT), where she teaches pharmaceutical analysis and analytical chemistry graduate courses.

About Compliance4All:

Compliance4All (http://www.Compliance4All.com/) is a specialized offering from NetZealous, a Fremont, CA-registered organization. It is a source for a wide range of professional trainings, compliance trainings and consulting for the regulated industries. Compliance4All offers a broad range of high quality, affordable regulatory and compliance-related services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.

Many professionals in the various areas in which Compliance4All offers its trainings have benefited from the vast experience of its well-known speakers, who are reputed globally in their respective fields.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/