Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
27-03-2014
Webinar Description :
Device manufacturers are required to establish and maintain procedures to ensure all products and services received conform to their specified requirements. A significant number of product recalls due to component failures has resulted from firms’ failure to adequately control purchases. This webinar is intended to discuss adequate purchasing control requirements and in particular, to focus on auditing suppliers to ensure that the purchasing control procedures are adequately established and maintained.
If you already have purchasing control procedures, you can still join this webinar to make sure your procedures contain all the necessary requirements for suppliers pursuant to applicable regulations. At the end of the webinar, you will become familiar with the good practices for purchasing control procedures including supplier requirements. Objectives of the Presentation: - To better understand purchasing controls
- To understand supplier requirements
- To understand what/how to audit suppliers
Areas Covered: - Statutes and Regulations
- Definitions
- ISO 13485
- Audit Principles
- Purchasing Controls
- Auditing Purchasing Controls
- Supplier Auditing: Decision Points
- Audit Planning, Frequency, Duration and Logistics
- What Items or Processes of the Suppliers to Audit
- How to Audit Suppliers
- Various Audit Approaches
- Quality Systems and Subsystems in ISO 13485
- Quality Systems and Subsystems under 21 CFR Part 820
- Comparative Overview of both ISO 13485 and 21 CFR Part 820
- FDA and ISO 13485
- Good Practices: Speaker’s Suggestions and Recommendations
Who will benefit: - Quality Professionals
- Compliance Staff and Officers
- Regulatory Affairs
- R&D
- CEOs
- VPs
- Attorneys
- Clinical Affairs
- Consultants
- Contractors/Subcontractors
- Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820
Why you should attend: - To better understand and adequately implement supplier requirements to survive an FDA inspection for purchasing control.
Instructor Profile Dr. Lim is President and Principal of Regulatory Doctor (http://www.regulatorydoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics including 510(k)s in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Currently Dr. Lim is an adjunct professor in regulatory affairs at Northeastern University in Boston, MA. Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00
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