In this FDA documentation best practices training for FDA regulated companies, learn the techniques ideas that will help identify effective methods designed to improve your document control systems.
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:
- 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
- Documentation department manager and staff
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
