Best Practices to Create FDA Audit Ready Quality Systems
Date: December 20, 2024
Duration: 60 Minutes
Time: 12 PM EST
- Key regulatory definitions and guidelines for QC, QA, QM, and QMS
- FDA’s expectations from QC and QA: Regulatory intent
- Best practices for creating robust QC and QA departments at companies of all size
- Common issues with combined QC and QA departments and how to avoid them
- Requirements for personnel, training, and documentation practices
- Applying concepts of QC and QA to all compliance areas: GMP, GLP and GCP
- Common FDA Findings
This seminar will discuss the common Quality Assurance and Quality Control related finding at an FDA audit and ways to address them. Key differences between QC and QA, along with best practices to manage the two aspects of quality for better performance and compliant practices, will be discussed. Easy solutions to common issues with QC and QA practices will be discussed using case studies and examples.
Whether you are setting up a new quality system or managing an existing one, this seminar will give you tips to reasonable methods for easy compliance with FDA requirements. This webinar, presented by a leading QA expert will discuss the key elements of QC and QA, the Quality Manual, and the overall QMS from the perspective of an FDA auditor. Key components of each element along with tips to prioritize critical steps to compliance will be discussed. Special considerations in resource-limited settings will be discussed. What works and what doesn’t in creating QC and QA departments, training of personnel, documentation requirements, and compliance checks. The seminar will highlight key strategies to maintain high quality operations that can assure controlled operations, acceptable product, and robust documentation systems. Common errors and potential solutions will be discussed using examples and case studies.
This webinar will provide valuable assistance to all personnel in:
- Regulatory Affairs Personnel
- Quality Assurance Personnel
- Quality Control Personnel
- Project Managers – Regulatory and Clinical
- 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.
