Webinars >>FDA Regulations
Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility 
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All GMP manufacturing facilities need to be shut-down periodically for maintenance, cleaning, updates to equipment, and during holidays. Stopping production, no matter the duration, needs to be carefully managed to assure ongoing compliance of the facility. Shut-down and then return to service not only require additional resources and costs, it is a documentation and training burden that if not managed adequately, could lead to a regulatory nightmare scenario. Most shutdowns are highly complex and carry inherent safety risks. Shut-downs can be planned or accidental (for cause), each with its own nuances and risks. Planned shut-downs almost always add to facility improvement and robustness. These are opportunities for a complete check-up of equipment for ongoing performance, adding new equipment, making structural updates to the manufacturing suites, training of personnel, 100% cleaning, and other measures to upgrade facilities. The accidental shut-down while perceived as negative events, may also contribute to demonstrating the robustness of the facility depending of the timeliness of the corrective measures and the efficiency of the preventive measures. FDA expects all manufacturing facilities to have a written process and documentation of compliance for temporary shut-down and restart of the facility including steps for planning and execution to demonstrate the claimed aims of timely, safe, and risk-based approach.
Why should you attend:
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If you run a manufacturing facility, use a contract manufacturing facility, or plan to start your manufacturing facility, this seminar will provide training in one of the most critical and often ignored aspect of a manufacturing operation. Improper shut-down and restart process is one of the major findings during an FDA audit. Depending on where your facility is located, you may have to deal with short-term or even long-term shut-down of your facilities. This seminar, presented by a leading quality assurance expert, will discuss FDA expectations from the shut-down and restart process for a manufacturing facility for drugs, biologics, and combination products. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for FDA regulated industry using case studies and examples from the presenter’s vast experience helping manufacturing facilities of all sizes in dealing with temporary shut-down. The webinar will provide precise and complete list of measures and checklists to be implemented by FDA-regulated companies to bullet-proof their compliance.
Areas Covered in the Session:
  • Regulation and Requirements for GMP facilities regarding shut-down and restart operations
  • Validation of the shut-down process
  • What should be the criteria for very short-term shut-down such as on weekends to longer-term shut-down such as for weeks or months
  • The list of activities that can be complete during the shut-down phase
  • Ways to make the most of the shut-down – planned and accidental
  • Documentation requirements
  • Common FDA audit findings
Who will benefit:

This webinar will provide valuable assistance to: 
  • Manufacturing facility personnel
  • CMO
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: December 1, 2022
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar​
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com