In this CAPA training webinar, we will focus on ideas that will help identify effective methods designed to improve your response to process deviations and help you develop a standardized plan to fully resolve discrepancies so they do not recur.
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 Seminar:
- Understand the basis for complete documentation.
- Review the most likely areas for scrutiny.
- Establish effective procedures that will pass inspections with ease.
- Define adequate control measures to ensure compliance.
- Determine proper review techniques for records and reports.
- Rehearse effectively for regulatory audits.
- Documents required by the US-FDA.
- Handling electronic documents.
- Developing an SOP for generation and maintenance of documentation.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Regulatory affairs professionals
- Manufacturing and operations personnel
- QA managers and personnel
- Quality control personnel
- Facility maintenance and calibration personnel
- Logistics and supply personnel
- Any employee involved in regulatory audits
- GMP/QSR auditors
For More Information: