Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel 2010
September 22, 2010(Ended)
Online Webinar
Ready for Inspection by Hamburg`s FDA? Under Commissioner Hamburg`s
new enforcement policy, FDA has issued more warning letters more
quickly than it has in years. In some cases, the agency has even
skipped warnings and gone straight from inspectional observations to
injunctions and seizures. Clearly, the stakes will be higher at your
next inspection. The question is: What steps should you take now to be
ready for it?
The key to effective management of regulatory inspections is
effective preparation. Being well organized and confident during the
inspection means that your firm gives it`s best possible performance
which in turn gives the regulatory inspector the clear message that you
know your business thoroughly. In this webinar, you will learn the key
principles of the preparation of staff that will be expected to face
the inspector(s). This webinar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.
Areas Covered in the Session:
- Current trends
- Staff Training and Preparation
- Key steps to becoming inspection ready
- Facing the inspector - Competent, Confident, Credible, Knowledgeable
- Managing the inspection process
- Use of high level presentations
- Likely targets
- Know and respect the inspector`s techniques
- Behaviors to encourage
- Behaviors to avoid
Prices *
245 US Dollar (Early registration date: September 21, 2010)
Exhibition
No exhibition
Organization
Categories
Concurrent events
- Why Medical Device Companies Receive Warning Letters - Webinar by GlobalCompliancePanel 2010
- The Cosmetic-Cosmeceutical Distinction: Walking the Line in Developing Label Claims - Webinar by GlobalCompliancePanel 2010
- Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel 2010
- The ICF Process: Tips on Achieving Optimal compliance and Comprehension
- Project Management Certification Study Group - Information Year 2010
Important
Please, check the conference website for possible changes, before you make any traveling
arrangements
* Prices are for evaluation only.
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