Quality System Management Reviews – A Lean Compliance Toolkit
Summary
Even the most current FDA regulations and guidance documents don’t explain what inspectors want to see in a quality system management review. And yet, if a firm isn’t reviewing its quality system the right way, the firm will face an FDA warning letter citing company executives for “failure to implement an effective quality system….”
Drawing upon discussions with FDA, GHTF, ICH, and EMA officials, plus internal FDA documents and an analysis of FDA warning letters, this recorded seminar will show you how to avoid wasting time, minimize risks, and get the most powerful results from a quality system and annual product review.
Learning points
- FDA and EMA expectations of a quality management system review
- How FDA inspectors will end up seeing your review documents even if you choose not to provide them when first asked
- Key requirements for pharmaceutical, biotechnology, and medical device firms
- Four core components of an effective review of a quality system and medicinal products
- Six problems that continue to plague the industry – and how to overcome them
- What inspectors will ask for, what to provide, what not to … and why
- How to avoid going overboard – and still minimize risk
- A cost-effective, twelve-step annual quality system management program
And much more
Get 10+ documents for easy & quick implementation
- Template: QSMR certification letter
- Checklist: Preparing for the management review
- Checklist: Conducting the management review
- Checklist: Closing out & documenting the management review
- Sychronized audio-visual recording
- Slides with room for your own notes
- Customizable training certificate
- FDA presentation on demonstrating continual improvement: Robert Sausville, Pharmaceutical Quality Systems – The Foundation for Continual Improvement
- FDA management review schedule
- FDA warning letters citing poor quality system management reviews
- EMA quality management system policy and expectations
And more
How it works
Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.
Note: CD will be shipped after payment has been received. See our Better Business Bureau-accredited online purchasing and return policy for questions.More benefits
- Efficiency: Elimination of travel means more affordable advice
- Productivity: Rely on technology tools to view the recorded seminar and get the reference materials
- Veteran expertise: Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
- Environmentally sound: Spare our environment with less travel and a digital download
