Date: | December 2, 2015 - 10:00am - 11:00am |
Timezone: | (GMT-05:00) Eastern Time (US & Canada) |
Location: | 161 Mission Falls Lane, Suite 216, Fremont, CA, 94539, United States, NetZealous - Compliance4All |
Website for Event: | http://bit.ly/1Ms42fv |
Topic: | Health Products and Services |
Description: | Overview: 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??? Who Will Benefit: Quality Control and Quality Assurance 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, |
Contact Name: | Event Manager |
Contact Email: | support@compliance4All.com |
Contact Phone: | 18004479407 |