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.
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.Learning Objectives:
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services
Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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