Facility Operations, Maintenance, and Calibration

Why Should you Attend:

Is your facility program comprehensive and proactive, or does your maintenance department spend more time in damage control mode? Are your facility-related documents in need of a 'Quality' upgrade? Do you hope that regulatory auditors stay away from your critical utilities because of weaknesses in those areas?

This training class describes the mechanics of a sound maintenance program from a ‘Quality’ perspective, including the major issues that are typically emphasized during regulatory audits. You will learn how to develop thorough maintenance documents that are clear and confusion-free. Additionally, you will discover how to perform and document corrective work in a manner that eliminates ambiguity and misunderstanding.

Areas Covered in the Webinar:

• Minimize operational downtime by maximizing equipment efficiency.
• Create efficient maintenance plans that comply with FDA guidelines.
• Learn how to prepare better for regulatory audits.
• Create a 'compliance mindset' throughout your facility department.

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:

• Facility maintenance and calibration personnel
• QA managers and personnel
• Manufacturing and operations personnel
• Supervisory and field personnel

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 25-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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