EMEA Inspections of U.S.-Based Facilities: From Brussels to Boston, Be Prepared Or Risk Your EU Sales
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If you want to continue marketing drugs in the EU, you need to know what you're dealing with when the EMEA comes knocking on your door.
Before they target you, take action to ensure you're doing everything you can to be in compliance with the EMEA.
Here's how ...
In this 90-minute Encore presentation, Peter Smith, inspections expert with PAREXEL Consulting, will describe in detail the EMEA foreign inspection process. He'll examine the rules governing them and explain how EMEA inspections differ from those of the FDA. He'll also present the milestones leading up to the inspection and what to expect on inspection day. He'll identify who you should have in place for the inspection, give tips on how to manage the inspection and explain what to expect post inspection.
Sign up your entire team to listen in and discover:
- The specific directives and guidelines that govern an EMEA inspection
- Three major differences between EU and FDA GMPs
- 13 elements of EU quality assurance and quality control
- 12 requirements of EMEA's Product Quality Reviews
- What inspectors will look for to determine compliance
- Three key staff members to have in place for the inspection and their roles
- How documentation requirements are similar to, and different from, FDA rules
- EMEA's self inspection requirements
- Six inspectional focus points — where the inspector will be looking closest
- Steps to prepare for an EMEA preapproval inspection
- Seven major differences in FDA and EMEA inspector methodology
- Eight things that will happen post-inspection
- Where you can become involved to affect conclusions
- Future trends of EMEA inspections — will they become more or less like the FDA?
Register now and you'll have a full understanding of how to comply with, prepare for and manage EMEA foreign inspections. Plus, you'll get an opportunity to ask your toughest questions during the Q&A session.