Five Steps to Manage the Temporary Shutdown and Restart of a GMP Facility
Date: January 24, 2025
Duration: 60 Minutes
Time: 12 PM EST
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.
- 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
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
