Quality Agreements and Annual Inspections

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 product.

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. 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: 

To avoid 483's, Warning Letters and a Consent Decree. 

Areas Covered in the Session:

• What is a Quality Agreement???
• 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

• Quality Control and Quality Assurance
• Senior Management
• Regulatory Affairs
• CMO Leadership
• Quality Systems Personnel
• R&D and Engineering Staff
• New Product Development
• Compliance Managers
• Manufacturing Engineers
• Consultants

Contact Detail:

NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://bit.ly/1Ms42fv