- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
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.
why should you attend
This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance; your firm’s CAPA system is useful and meaningful.Click to View the Pricing Plan
- Regulatory Requirements
- FDA QSR
- ISO 13485
- Elements of a cross-procedural CAPA program
- Applications of CAPA
- CAPA Data, and best practices for its use
- Application of risk management to CAPA program
This CAPA compliance training 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 will be explained.
WHO WILL BENEFIT
This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- QA management
- CAPA coordinator
- Regulatory Affairs management
- Executive management
- Quality system auditors
Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.
Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.
Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.View all trainings by this speaker
Writing Ethical, Focused and Credible Internal Audit Reports
Speaker: Philip VassalloPrice: $285
Moving from an Operational Manager to a Strategic Leader
Speaker: Chris DeVanyTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Logistics Channel Incoterms Standards
Speaker: Dr. Rossano V. GeraldTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.