Conducting an Effective Quality System Management Review 2014 is a webinar dedicated to
- What the investigator will ask for vs. what to provide – and what not to
- Current FDA expectations and enforcement related to management reviews
- Six key challenges to overcome
- How to define a review that will meet the requirements of FDA, EMA and other regulatory health agency expectations
- How to avoid going overboard and still minimize risk
- Four elements of an effective quality systems management review
- Twelve (12) steps to consistently prepare for, conduct, and document effective management reviews
- How to structure the review to maximize time and results
Conducting an Effective Quality System Management Review 2014 brings together:
- Regulatory affairs managers and professionals
- Quality managers and professionals
- Vice-presidents of quality, regulatory affairs and compliance
- Directors of quality and compliance
