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
Who Will Benefit:
- 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
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, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training.
Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry.