Quality Agreements and Annual Inspections
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Instructor Profile Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems,
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description
This webinar will discuss about That 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 this production in particular, we will discuss how parties involved in purchasing critical raw materials that can generate patient risk and when the contract manufacturing of drugs have to utilize Quality Agreements to assure drug quality, safety, and efficacy.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why should 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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives 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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit Quality Control and Quality Assurance Senior Management Regulatory Affairs CMO Leadership Quality Systems Personnel R&D and Engineering Staff
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
How this Webinar works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answers to your queries through interactive Q&A sessions via chat
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com