The Controls for Outsourcing Manufacturing and Testing - Webinar By GlobalCompliancePanel
About this event
The process of auditing and qualifying contractors and assuring compliance quality goals are maintained, will be explained.
This webinar will use many graphics to explain its important points.
Why should you attend: This course will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements. The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client. These industry requirements are given in CFR Part 211.22(a), ICH Q7A 2.22-8, ICH Q7A 16, ICH-Q10 and Part 820, Subpart E.
The FDA has begun to more closely scrutinize the control of outsourcing because they have observed a frequent pattern where the firms allow contractors to completely control QA responsibilities.
Areas Covered in the Session:
Defining and Analyzing the Outsourcing Environment.
Regulatory Requirements For Outsourcing-Drugs & Devices
Planning For Outsourcing
The Resourcing Lifecycle
The Quality Agreement-Defined Responsibilities
Design and change control
Maintaining control and problem solving
Post-approval aspects of outsourcing
Quality Improvement and Resourcing
Covering the loopholes
Who Will Benefit:
Purchasing, Procurement, Outsourcing Depts
All of Quality
Live : $245.00
Corporate live : $995.00
Recorded : $295.00