What Should Be in a Certificate of Analysis per FDA?
Date: May 22, 2024
Duration: 60 Minutes
Time: 12 PM EST
Why should I attend:
- Comply with FDA Standards: The Certificate of Analysis (CofA) is a vital document that certifies the quality control testing conducted on drugs or formulations. Our seminar will shed light on the FDA’s requirements, ensuring that you stay on top of regulatory compliance.
- Understand CofA Components: The lack of a full definition for CofA may raise questions. Fear not! We will break down the essential elements that must be included in every CofA, such as test descriptions, limits, and actual results.
- Comprehensive Specifications: Learn how to establish comprehensive specifications for various components, from raw materials to outgoing finished products, as mandated by GMP standards.
- Crafting CofA Templates: Crafting an effective CofA template can be challenging. Our seminar will guide you through creating a well-structured CofA, complete with a header, body, certification and compliance statements, and a footer.
- Improved Compliance: By mastering the intricacies of CofA, you will ensure that your products comply with the required specifications, earning your customers’ trust and confidence.
- Quality Assurance: Elevate the quality control process by understanding the importance of each element on the CofA and ensuring that all specifications are met consistently.
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Drug discovery and development professionals (R&D and CMC)
- Clinical Research Professionals
- Principal Investigators
- Site Managers and Research Coordinators
- Contract Research Organizations (CROs) Staffs
- Institutional Review Board (IRB) Members
- Clinical trial managers
- Project Managers and Clinical trial specialists
- Pharmaceutical and Biotech Industry Professionals involved in clinical trial planning and execution.
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.
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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.
