Quality Agreements and Annual Inspections
Instructor: Jerry Dalfors
Product ID: 500967
Description
This webinar will discuss how parties involved in purchasing critical raw materials can generate patient risk and when the contract manufacturing of drugs have to utilize quality agreements to assure drug quality, safety, and efficacy.
Instructor: Jerry Dalfors
Product ID: 500967
Description
This webinar will discuss how parties involved in purchasing critical raw materials can generate patient risk and when the contract manufacturing of drugs have to utilize quality agreements to assure drug quality, safety, and efficacy.
Make sure our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (cGMP) as well as vendors supplying product specific raw materials unique to the product. Quality agreements are required for the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), as well as finished drug products from a CMO, combination products, and biological drug products. The intent of this webinar is to ensure we gain the proper perspective of the terms related with “manufacturing” which includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit.
Why Should you Attend
Manufacturing pharmaceutical products or materials may involve many discrete unit operations and activities. The entire process may be conducted by the owner of the drug, or, alternatively, the owner may engage an outside party or parties to complete the entire manufacturing process, or one or more discrete operations, under the contract. In this document, when discussing the roles and responsibilities of the parties to such contractual relationships, we will refer to the party that introduces (or causes the introduction of) a drug into interstate commerce as the Owner of the drug, whether such drug is covered by a marketing application/license or no. In this guidance, outside entities performing manufacturing operations for the product Owner are called Contracted Facilities.
Objectives of the Presentation
Defining the who and what of contract manufacturing including vendor suppliers for specific raw materials
Establishing responsibilities of critical vendors and CMOs
Contract manufacturing and quality management
Documenting contract manufacturing arrangements using the quality agreement or agreements
Elements of a quality agreement
Objective evidence to demonstrate compliance
Contract laboratories are contracted facilities subject to CGMP requirements
Who can Benefit
Quality Departments - Quality Control and Quality Assurance
Regulatory
CMO Leadership
Production Leadership
For Registration-
http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500967?expDate=August19_2015_GMP-Standard=Channel=printweek
Note : Use coupon code 1371 and get 10% off on Regsitration