FDA Inspection and Respond to 483 & How to Prepare them - 2017
- Start Date:
- Tuesday, 8 August, 2017
- End Date:
- Tuesday, 8 August, 2017 11:00am
- Health & Nutrition
Overview:In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection.Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Areas Covered in the Session:Personnel PreparationFacility needed to support inspectionBehavior during inspection-what not to signInternal/ Mock audits483 responseWho Will Benefit:Engineering PersonnelEngineering ManagementQuality ManagementCorporate ManagementManufacturing ManagementDivision ManagementSpeaker Profile:Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.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