Live web cast Part 1 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive systems by Angela Bazigos

Website https://compliance2go.com/product/?pid=CP2014-409 | Edit Freely

Category Biotechnology , Medical Device , Pharmaceutical

Deadline: January 29, 2015 | Date: January 29, 2015

Venue/Country: Houston, U.S.A

Updated: 2015-01-14 16:18:07 (GMT+9)

Call For Papers - CFP

It is critical to any pharmaceutical manufacturing operation that an effective quality management system is operational and functioning as intended. For the US market, the FDA regulates that industry very actively through challenging and well-established regulations. Internationally, there are various country-specific regulations but standards for pharmaceutical manufacturing quality are largely outlined in Q10 principles and in the established principles of Quality Risk Management (QRM), which are part of ICH, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH is an organization that covers the science and technical parts of drug registration through discussions between regulators and the pharmaceutical industry in Europe, Japan and the US. The mission of ICH is to achieve greater harmonization to ensure that medications are safe, effective, and of high quality and that the drug registration process is efficient.

Why should you attend :

To understand current international guidance, principles, and best practices to achieve quality in pharmaceutical manufacturing. While ICH focuses primarily on Europe, Japan, and the US, this class is valuable to expose and train attendees from other countries and regions on these basic principles.

Who Will Benefit:

Business Owners ,Senior Managers/Managers and Leaders in:

Quality Assurance

Production and Operations

Product Development

Regulatory Affairs

Marketing/Advertising

Labeling

Areas Covered in the Session:

Effect of ICH on pharmaceutical quality

Principles of QRM

Benefits of Proactive Quality Systems

What are COGS and what happens when they fail?

Importance of management responsibility in quality system management

Importance of good documentation practices

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance