Knock, knock, who’s there? Are you ready for an FDA inspection?
What Regulatory, Quality & Compliance Professionals Need to Know
Take your FDA Inspection to the next level of reliability with this webinar. WCS Course Instructor Susanne Manz, (MBA, MBB, RAC, CQA) FDA Consultant will create an inspection readiness plan, so you are well prepared for an FDA inspection.
Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters.
This webinar will help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
Why Should You Attend
An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stress and lead to much more favourable results.
This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar.
- FDA Inspection approach
- Inspection preparedness strategy and planning
- Key roles during an inspection
- SME (Subject Matter Expert) training
- Checklists for preparing
- How to manage an inspection
- Common mistakes to avoid
- How to respond to inspection observations
Who should Attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry and all FDA Regulated Industries personnel
- Quality Engineers
- Compliance Specialists
- Compliance Managers and Directors
- Management Representative
- Quality Managers and Directors
- Business Leaders wishing to present a professional and compliant organisation
- Cross-functional leaders wanting to make sure their organisations are well prepared
- Anyone involved with an FDA or NB inspection
Susanne Manz (25+yrs exp.)
Consultant | Educator | Author
Baltimore, Maryland Area
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals