Overview:
Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.
Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.
Speakers
Steven Wachs,
Principal Statistician ,
Integral Concepts, IncSteven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control.
Steve is currently a Principal Statistician at Integral Concepts, Inc. where he assists manufacturers in the application of statistical methods to reduce variation and improve quality and productivity. He also possesses expertise in the application of reliability methods to achieve robust and reliable products as well as estimate and reduce warranty.
Who Should Attend
- Quality Auditors
- Compliance Officers
- Executive Management
- Managers/Directors/Supervisors and Personnel related to:
o Regulatory Compliance and Regulatory Affairs
o Quality Management System
o Quality Assurance
o Quality Control
o Product
