In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them.
Why You Should Attend:
In order to assure your company is in substantial compliance, you must have an audit team that is trained to identify noncompliances present in both your quality system and that of your suppliers. This session shows you the most efective way to identify those employees who will be the most effective auditors, and how to train them to accurately assess the compliance status of your company and suppliers. Also covered will be the responsibilities of each position on the audit team, as well as the audit process, including several supplier-specific implications. Inadequate performance of your audit team can have serious adverse effects in the form of both product and regulatory impications.
Areas Covered in the Seminar:
- Importance of the Audit Team Coordinator.
- Auditor Selection.
- Auditor Training Requirements.
- Auditor Responsibilities.
- Audit Planning.
- Pre-audit Preparation.
- Audit Performance.
- Post-audit Requirements and Tasks.
Who Will Benefit:
This webinar will provide valuable assistance to all companies that are subject to FDA regulations, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Top management
- Regulatory/quality management
- Internal auditors
- Supplier auditors
- Industry personnel who wish to implement a supplier or internal audit program
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. 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.
