QCC Contents

Resources (member access only):

  • Webinar Recordings
  • Internal Resource Kits
  • Whitepapers
  • Newsletter Archive

 
Key Topics (member access only):

  • 21 CFR Part 11 Guidelines
  • Audit Readiness
  • Annex 11 Guidelines
  • CAPA Best Practices
  • China SFDA GMP Regulations
  • Compliance and the Supply Chain
  • Computer Systems Validation
  • Design Transfer Guidelines
  • Failure Investigations
  • GMP Lessons from Toyota
  • GMP Training Expectations (EU and US)
  • US FDA and Risk Management
  • Responding to 483s and Warning Letters
 

Quality Compliance Coach

Welcome to Quality Compliance Coach (QCC)

QCC is a subscription service from Kaplan EduNeering and leading consulting firm EduQuest that reinforces quality as an integral aspect of your company’s culture. QCC provides regulatory updates, quality best practices and more advanced training for Kaplan EduNeering clients in the pharmaceutical, medical device and biologics sectors.

Not a subscriber? Contact Pat Thunell at pat.thunell@kaplan.com to learn more.

What's New:

3/21/12: New Whitepaper: China SFDA Medical Device Regulations: An Insider's View...Log in to register, then scroll down to the new paper.

3/16/12: Webinar Recording: Auditing and Managing Suppliers & Contract Manufacturers: The recording of our March 14th webinar is now available. After you log in, the link to the recording will display below under "Latest Webinar."

01/05/12: Q1 Regulatory Update: Why the FDA’s Membership in PIC/S Matters...Log in to register, then scroll down to view this issue (PDF).

11/16/11: Webinar Recording: What You Must Know about Form 483s and Warning Letters...Log in to register to listen and view recording, as well as download slides