Good Documentation Practices for FDA-Regulated Industry
Date: May 14, 2025
Duration: 60 Minutes
Time: 12 PM EST
One of the things that the FDA most commonly finds during audits is bad documentation practices. Companies are frequently cited for missing or incomplete records, disorganized documents, lack of SOPs, inconsistent documents across the organization, non-validated electronic systems, non-certified copies, poor correction practices, and many other violations. The expectation from the industry is that all regulated tasks are to be adequately documented and submitted for review in a timely fashion and available for review during audits. Unacceptable documentation practices lead to loss of business, credibility and delays.
Good documentation practices are strictly expected by FDA, however, there is little guidance on the specific requirements and best practices, leading to high degree of variability in documentation practices. The core principles of good documentation practices are independent of the kind of organization. This seminar will discuss the FDA expectations for documentation practices, training requirements, SOP requirements, and review needs. Best practices based on regulatory requirements, scientific logic, and practical experience will be discussed. Electronic and paper documentation practices will be discussed using case studies to emphasize the common mistakes and potential solutions.
If you are involved in creating, storing, managing, reviewing, training, compliance, archiving and organizing documents for FDA-regulated tasks, this seminar will provide valuable suggestions about various aspects of a Good Documentation Practices, various elements of the documentation, role of various personnel, and troubleshooting common issues. The dos and don’ts of documentation, filing practices, electronic documentation and audit trails will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.
Objective of the Presentation:
At the end of this webinar, you would understand:
- Principles of good documentation practices
- Quality control and quality assurance practices for documentation
- Listing key documents for various organization
- Best practices for training personnel, periodic reviews, archiving and storage
- Electronic and paper documents
Common errors and potential long-term and short-term solutions
Who will benefit:
- Regulatory affairs professionals
- Senior management executives (CEO, COO, CFO, etc)
- Documentation management personnel
- Records and storage personnel
- Drug discovery and development professionals (R&D and CMC)
- Clinical trial managers
- Project Managers and Clinical trial specialists
- Regulatory Compliance Associates and Managers
- People investing in FDA-regulated product development project
PhD, RAC | CEO, FDAMap
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Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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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.
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