Quality Management System effectiveness: What you can impact in reactive versus proactive systems

Website https://compliance2go.com/product/?pid=CP2014-433 | Edit Freely

Category Pharmaceutical

Deadline: April 15, 2015 | Date: April 15, 2015

Venue/Country: Online, U.S.A

Updated: 2015-03-27 18:15:34 (GMT+9)

Call For Papers - CFP

This is Part I of two webinars. Part 1 cover Quality Management Systems in the US; Part 2 covers ICH, QRM, and COGS.

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.

Why should you attend :

To understand current guidance, principles, and best practices to achieve quality in pharmaceutical manufacturing. While ICH focuses primarily on Europe, Japan, and the US, this class will specifically address US regulation, which provides valuable exposure and training for attendees from other countries and regions regarding how the FDA evaluates Quality Management Systems. COGS, QRM

Areas Covered in the Session:

US pharmaceutical regulations

Benefits of Proactive Quality Systems

Importance of management responsibility in quality system management

Importance of good documentation practices

Who will benefit: (Titles)

Business Owners & Senior Managers/Managers and Leaders in:

Quality Assurance

Production and Operations

Product Development

Regulatory Affairs

Marketing/Advertising

Labeling

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

You can also Buy :

""Part 1 - Quality Management System effectiveness: What you can impact in reactive versus proactive systems" + "Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive""

"Part 2 - Quality Management System effectiveness: ICH Q10 principles, impact of failure on COGS, principles of QRM, what you can impact in reactive versus proactive"