This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.
 
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.

Areas Covered in the Seminar:

• Introduction.
• Guidance documents QS regulation.
• Major FDA 483 points.
• Trends in FDA.
• Determining best practice for the supplier audit.
• Conducting a thorough audits.
• FDA import detention prevention.
• Questions to ask during the supplier audit.
• Questions & Answers.

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