ComplianceOnline, Online Event
2013-11-07
Why Should You Attend: - Do your investigations completely resolve the discrepancies?
- Is product kept in a safe condition regardless of the extent of problems?
- Do your employees know how to define and implement adequate CAPAs?
Since regulatory inspectors look very closely at non-conformances you have to have a robust CAPA process and its success is dependent on two things: a well-thought out strategy, and employees specifically trained to handle the discrepancies. This CAPA webinar will teach specific techniques to ensure organizations are prepared to fully investigate and prevent out-of-specification situations. We will focus on standardizing your investigatory techniques so that every deviation is handled the same way. Further, you will learn techniques that will help you create solid CAPAs that are unambiguous and complete. We will also examine applicable warning letters and 483s so that your company doesn’t make the same mistakes as other organizations. By building compliance into every aspect of your operation, you can concentrate on getting more quality product out the door. Areas Covered in the Webinar: - Understand the basis for complete documentation.
- Review the most likely areas for scrutiny.
- Establishing effective procedures that will pass inspections with ease.
- Defining adequate control measures to ensure compliance.
- Determining proper review techniques for records and reports.
- Rehearsing effectively for regulatory audits.
- Reviewing the documents required by the FDA.
- Developining an SOP for CAPAs and investigations.
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