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  HUM-MOLGEN -> Events -> Courses and Workshops  

Best Documentation Practices for FDA Compliance

  October 08, 2013  
ComplianceOnline, 2600 E. Bayshore Road

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.
Organized by: ComplianceOnline
Invited Speakers: 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.
Deadline for Abstracts: 2013-10-17
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701774?channel=hummolgen
E-mail: referral@complianceonline.com
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