Webinars>>Good Documentation Practices
Good Documentation Practices for FDA-Regulated Industry
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.
Why should you attend:
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:
Who will benefit:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: email@example.com