Effective Records, Document Control, and SOPs

Do you have unapproved or outdated documents in circulation? Are your SOP revisions being done in an uncontrolled or inefficient manner? Does your production team use confusing formats that create uncertainty in record-keeping? This training class will examine the ideas associated with the development and control of quality documentation. We will discuss methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.

Areas Covered in the seminar:

• How to create uniform documentation that is easy to follow.
• Establish systems that will speed up review of new or revised documents.
• Eliminate common formatting problems that create confusion.
• Create more control over controlled documents in circulation.
• Ensure obsolete documents are removed from use.

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:

• Document control personnel
• QA managers and personnel
• Quality control personnel
• Facility maintenance and calibration personnel
• Manufacturing and operations personnel
• Any employee involved in regulatory audits

Instructor Profile:

Nick Campbell, is the founder of Sunriver Risk Management, a consulting firm that specializes in compliance training for the bioscience industry. He has spent his 20-year career working in operations for highly regulated industries, including the last 15 years in the 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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