CLP Simplified: Meeting FDA Requirements without Breaking the Bank
Date: June 25, 2025
Duration: 60 Minutes
Time: 12 PM EST
The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. The presenter will use case studies from his extensive experience to emphasize optimum requirements to meet FDA’s requirements rapidly, efficiently and economically.
This seminar will provide details of the regulations and practical tips to meeting regulatory requirements in diverse setting with limited resources. Attendees will be provided with list of SOPs and best practices, and sources to get additional information. If you are planning to test drugs or biological substances, this seminar will give you useful tips from the presenter’s extensive experience about FDA’s expectations from GLP studies. This seminar will discuss the current rules and practical tips for being compliant with the FDA expectations. This seminar will act as a great building block to get you started on GLP requirements and provide an excellent base for additional training, as needed.
- Principles of GLP as defined by FDA and OECD
- FDA guidance documents for preclinical and sample testing
- FDA’s enforcement of GLP compliant organizations
- Difference between GLP and non-GLP studies
- Difference between CLIA and GCLP
- SOPs, documents, reports and other documents in GLP labs
- Facility, personnel, and business aspects of GLP
- Drug discovery scientists
- Safety pharmacologists
- Toxicologists
- Scientists in lead optimization
- Project Managers
- Regulatory Vice Presidents, Directors and Managers
- Lab testing professionals
- Compliance professionals
- Auditors
- Attorneys – In-house or Outside Counsel
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.
