ComplianceOnline

Internal Audits and Supplier/Subcontractor Audits

Instructor: Jeff Kasoff
Product ID: 701014
Training Level: Basic
  • Duration: 60 Min

recorded version

$199.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This session will detail the best methods or training auditors, and include the best methods for performing internal audits as well as audits of suppliers and subcontractors.

Description

This webinar will provide valuable assistance to all regulated companies, since internal and external auditing are requirements across the industry.

The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit program, your company needs an effective audit team. This session will detail the best methods or training auditors, and include the best methods for performing internal audits as well as audits of suppliers and subcontractors.

Areas Covered in the seminar:

  • Methods for auditor training.
  • Establishment of an internal audit program.
  • How to perform internal audits.
  • Establishment of an "external" audit program.
  • How to perform supplier/contractor audits.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies, since internal and external auditing are requirements across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Executive/senior management
  • Regulatory management
  • QA management
  • Purchasing management
  • Quality system auditors

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.

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