483 Covers a Broad Gradation of Problems
- Start Date:
- Wednesday, 25 October, 2017
- End Date:
- Wednesday, 25 October, 2017 11:30am
- Health & Nutrition
Overview:How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA's review in your favor as it is well organized, succinct and provides proper documentation. Why You Should Attend:Your failure to understand and properly respond to a 483 issued to you at the conclusion of an FDA inspection may quickly lead to an administrative or a legal action that can have an immediate adverse effect on a firm's business.
Areas Covered in the Session:What the 483 meansHow to interpret the 483 - "How bad is it?"Managing the 483 discussion with the FDA at the conclusion of the inspectionResponding to the FDA in writing Who Will Benefit:ManufacturersFDA ConsultantsLegal CounselRegulatory Affairs ManagersQuality Assurance Staff Speaker Profile:Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Netzealous LLC DBA - Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- Netzealous LLC DBA - Compliance4All