Outsourcing and contracting is continuing to increase in the pharmaceutical industry. Regulations have been in place for some time specifying requirements that ensure that appropriate controls are in place.
This webinar will discuss the history of the regulations with emphasis on changes particularly specific to the Good Manufacturing Practices
A short overview of the GMP’s quality systems will provide an overall picture of how contracting fits into the pharmaceutical Manufacturing and marketing.
Pharmaceutical Product Lifecycle will be discussed.
For each regulation, the citation specific to the topic of contracting/outsourcing will be presented in how it relates to the quality agreement.
Why should you Attend:
Obviously, both quality and compliance will be improved. This will reduce the risk of compliance citations and/or “surprises and showstoppers”
You will better understand the difference between suppliers and contractors and the requirements for contracting and outsourcing pharmaceutical operations activities, and the related requirements.
Because contract activities began in R&D and continued throughout the pharmaceutical product lifecycle, to better understand the requirements and how they change as a product reaches commercial development and is released into the marketplace.
Who Will Benefit:
Senior Management-they must learn and understand what’s requirements are all about in order to manage the function
Supplier & Contractor Quality Personnel
Purchasing and Finance
Shipping and Receiving
Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/29nElym
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