This in-person seminar will cover two areas that are critical for compliance: Supplier Management and CAPA.
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management subsystem meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!
This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system detailed. This seminar will also answer the question: What do the FDA investigators look for during their inspection of your CAPA program? This seminar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation
If you want these critical subsystems of your QMS to be in substantial compliance, and to be as streamlined as possible, you cannot afford to miss this.
- Supplier Selection
· Review of FDA and ISO requirements
· Types of suppliers that must be qualified
· Defining critical suppliers
· Risk-based Supplier Classification
· Outsourced processes
· The Quality Agreement
· Recommended Practices
- Supplier Assessment
· Review of FDA and ISO requirements
· Recommended Practices, including Estabshment of Quality Objectives
· How to avoid “Death by Supplier Audit”
· Documentation requirements
• Applicable Regulations
• Contents of Procedure(s)
Elements of a CAPA program
– Detection of nonconformance
– Identification of root cause (Investigation)
– Review of Investigation
– Determination of Corrective/Preventive Action
– Performance of Corrective/Preventive Action
– Implementation of Corrective/Preventive Action
– Effectiveness of Corrective Action
Root Cause: A Primer
- Identification of root cause investigation
- Popular root cause techniques
How FDA Trains Its Investigators for CAPA, and Best Practices for Preparation
- Review of FDA guidance documents
- Corresponding best practices for compliance for each inspectional practice
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.