Annual Inspections 2015 - Webinar on Quality Agreements and Annual Inspections

Overview:
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
Speaker Profile:
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, 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.
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/1Ms42fv