FDA's Current Thinking for Industry cGMPs for Phase 1 INDs

This US FDA final guidance documentation training program will give an insider’s insight into the final guidance and discuss the rationale for such. The course will also elaborate CGMP statutory and regulatory requirements and recommendations for complying with the statue.

Why Should You Attend:

The US FDA has issued a final guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended solely in Phase 1 clinical trials.

Who Will Benefit:

This webinar will provide valuable assistance to those persons producing drugs and biological products (investigational drugs) for use during phase 1 development in complying with US CGMP requirements. The employees who will benefit include:

Management

Production Employees

Quality Control Managers and Personnel

Process Chemists and Personnel

Laboratory Personnel

Instructor Profile:

Sandra N. Whetstone is a former US Food and Drug Administration (FDA) executive with more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Her primary area of expertise is in the practical application of the US Food, Drug and Cosmetic Act, promulgating regulations under the acts, developing and implementing compliance programs for the FDA regulated industries, and developing enforcement strategies for effective compliance and consumer protection covering the full range of products under FDA’s jurisdiction.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/fda-current-thinking-for-industry-cgmps-for-phase1-inds-webinar-training-700155-prdw?channel=sciencedz