What will FDA expect and request from your firm during Design Control portions of Inspections?

Why Should You Attend:
Many companies are confident that their design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue. This presentation will review the sections of the QS Reg. design control regulation which represent high compliance risk to firms. Actual design control/FDA data will be discussed, which shows the agencies' design control compliance directions. FDA investigator techniques will also be discussed.

Learning Objectives:

• What FDA expects and will request from you during your design control portion of your FDA inspection.
• How QSIT inspections related to design control systems and its attendant record keeping are performed by FDA.
• How change control issues affect design control inspections.
• What constitutes a good design control process auditing procedure.
• How do how to counteract a possible design control FDA 483 cite.
• How risk management fits into design control compliance.

• Introduction.
• Guidance documents/ QS regulation.
• Major FDA 483 points.
• Trends in FDA warning letters.
• Determining best practice for the design control audit.
• Conducting a MORE thorough audit.
• FDA 483 point issuance prevention.
• Questions & Answers.

Who Will Benefit:

• Senior executives of pharmaceutical and device firms
• Quality Unit Vice Presidents, Directors and Managers
• Vice presidents, Directors and Managers of operations
• Quality engineers and field auditors
• Regulatory and Compliance Management
• Consultants
• Quality System Auditors

Instructor Profile:
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts and software auditing techniques. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.

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