FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices



This course will be immensely helpful to Supplier Auditors and Supplier quality engineers who would like a deeper understanding of the fast changing medical device regulations that are pertinent to bringing in a new supplier and maintaining them in their quality system through routine supplier audits and related documentation. In addition, Quality Engineers, Regulatory Managers, Production leads/Inspection Supervisors, Marketing/ Supply Chain Department Leads, Manufacturing Engineers associated with Production Operations, Quality Control and Quality Assurance Management,Supplier Managers, Procurement Managers, OEM (Outside Equipment Manufacturers) and Suppliers to medical device industry will be able to add new tools to their tool box. Internal Auditors and R&D Engineers will also find this webinar useful for fulfilling their responsibilities in onboarding suppliers and in long term supplier management.

Supplier management is an integral part of any quality system in regulated industries. Quality System regulation (QSR) and ISO 13485 have specific supplier management requirements that you are answerable to. FDA is getting more rigid about supplier audits and more stringent on managing the suppliers and outside equipment manufacturers (OEM) in the medical device industry. The goal of this webinar is to educate you on the key areas that you need to focus on in the ever growing, globally important arena of supplier management in the medical device industry.

Areas to be Covered:

Fundamental areas that must be focused on for supplier management from A to Z for on-boarding and sustaining suppliers
OEMs throughout the product life cycle to fulfill quality and regulatory requirements of your products.
Supplier Qualification, based on their Quality System
Product Development Process (PDP)
ISO and other regulatory certifications
Criticality of the products to your supply chain
Classification of suppliers based on type of sourcing
Classification based on your readiness to adapt if the supplier moved out of producing
Uniqueness of the product/process to your supply chain
Factors while auditing a key supplier during the facility audit of a supplier to your globally distributed medical devices
Key acceptance and evaluation criteria in supplier audits.
Criteria for establishing frequency of site audits for key suppliers.
Audit reports and follow up with SCAR (Supplier Corrective Action Requests)
First article inspection and its correlation to pre-established SPC (statistical process control), CTC (critical to customer) and CTQ (critical to quality) criteria, supplier process control and capability assessment for sample inspections.
Role of supplier quality for new product release authorization.
Key factors to look for in Supplier’s manufacturing quality plan
What to include in your supplier quality plan for long term protection of your device during its life cycle.
Key areas of focus for supplier quality engineers in receiving materials (raw materials to finished goods that may just be marketed by your company)
Role of suppliers such as testing laboratories like biocompatibility testing labs and suppliers such as sterilization facilities.
Training of suppliers to adhere to your quality expectations based on nature of the products supplied (differential treatment of dock to stock items to a sole source of a patented product).
Regulatory requirements for supplier changes and changes such as raw material or process changes at the supplier facility that may impact your product quality

Who will Benefit:

Supplier Auditors
Supplier quality engineers
Quality Control
Quality Assurance
Quality Engineers
Regulatory Managers
Production leads/Inspection Supervisors
Marketing/ Supply Chain Department Staff
Manufacturing Engineers
Production Managers
Procurement Managers
OEM (Outside Equipment Manufacturers)
Internal Auditors
R&D Engineers
Suppliers to medical device industry

Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.


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