Best Documentation Practices for FDA Compliance

Why Should You Attend:

• Do your reports completely explain the relevant issues?
• Are your SOPs accurate, relevant, and useful to your operators?
• Do your employees maintain proper control over your documentation systems?

A successful documentation system ensures that no items are left open and unresolved. This webinar will teach specific techniques to ensure organizations are in compliance with regulatory guidelines concerning documentation. We will focus on how to standardize your documentation so that every report or record is handled the same way. Further, you will learn techniques that will help you create solid procedures 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:

• The basis for complete documentation.
• 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.
• 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
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants

Instructor Profile:

Nick Campbell, has spent his 25-year career working in operations for highly regulated industries, including the 20 years in the nuclear power, pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada.

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