Vendor Qualification - Designing and Implementing an Efficient and Compliant Vendor Program (Biotech)
|Event Date/Time: Aug 08, 2011||End Date/Time: Aug 08, 2011|
This webinar will provide valuable information on the regulations of the USA, Canada and the EU as they apply to your management of vendors of services and materials and how the agencies are changing their interpretations. We will examine successful workable processes that are compliant with the regulations and yet efficient from a business perspective, and show how companies meet these stringent regulations.
The incorporation of risk management into the development and execution of the program will be highlighted for clinical as well as commercial products, irrespective of whether they are manufactured within your own plants or in your contract manufacturer's facilities. You will also see how companies run foul of the agencies resulting in warning letters as the agency steps up interpretation and enforcement and how from this information you will be able to assure that you do not suffer the same fate.
Areas Covered in the Seminar:
What the elements of a vendor qualification program are?
What regulations govern the vendor qualification program?
How the agencies are reinterpreting the regulations and enforcing them more stringently?
How to develop and implement a program that is both compliant and efficient - a tiered program?
What a compliant program looks like to the agency in this time of increased enforcement?
How to incorporate risk management into the vendor program so you can focus your resources in the most vulnerable areas?
The different challenges and how to manage them in the clinical trial and commercial stages.
What the agencies expect from you to convince them you are in compliance and in control?
How to manage vendors and contract manufacturers?
Where companies go wrong and get into regulatory hot water and how to avoid it yourself ?
Who Will Benefit:
This webinar will provide valuable assistance to all in pharmaceutical and biotech industries who manufacture products for clinical and commercial uses. The employees who will benefit include:
QA staff and management
Regulatory Affairs staff and management
QC staff and management
Project managers working in the CMC arena
Senior managers and executives