This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
Why Should You Attend:
Supply chain activities (including, the increase in outsourcing materials, components, manufacturing and services) have become more complex to manufacturers and oversight has become more challenging and complicated. Manufacturers are required to manage carefully their entire supply chain. Purchasing and supplier control deficiencies rank in the top 10 deficiencies related to warning letters. The FDA focuses on how companies are addressing procedures and their actual execution on: selection, evaluation, acceptance criteria establishment, communication process (including change notifications), controlling, and monitoring their suppliers and service providers among other related activities. As a result of recalls, there has been public concern regarding insufficient oversight of the entire supply chain from regulated companies.
This webinar will also compare GHTF Guidance (GHTF/SG3/N17:2008) on Control of Products and Services Obtained from Suppliers VS 21 CFR Section 820.50 Requirements. The webinar includes a challenges and conclusion session as well.
Areas Covered in the Webinar:
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA