2016 - Webinar on Raw Materials Risk Management in GMP Facilities and How to Avoid Non-Compliance

Description :
This webinar will help you understand the requirements laid down by US FDA for the regulated medical products industry in areas like increasing globalization and extended supply chains when coupled with the need to have tighter internal materials controls. We have observed that recently ,major problems of suppliers is caused by weak oversight of such sources. Poor cGMP, including change control or its lack, by vendors has resulted in major recalls and class action lawsuits. Due to this, U.S FDA cGMP has had a major shift in emphasis compliance audit, which affected various company response requirements, clinical trial expectations as well as product submissions.
Areas Covered in the Session :
The Globalization of the Regulated Medical Products Industry
The U.S. FDA's Shifting / New Emphasis
Core CGMP Expectations
Devices: QSIT and ISO 14971 focus
Pharma: Q10 Focus; and Q8 and Q9 "Lessons"
The Supply Chain
High Risk Areas - Based on Recent 483s and Field Experiences
Risk Ranking Schemes
Pedigrees
Related FDA Strategic Priorities
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that are looking to ensure compliance at their GMP facilities. Its principles apply to personnel / companies in the Medical Devices, Pharmaceuticals, Biologics, Commbination Products, Dietary Supplements fields. The employees who will benefit include:
Senior management
Middle management
CROs and Clinicals personnel
QA / RA
Medical personnel and Other healthcare professionals, staff and office personnel
Consultants
cGMP instructors