Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents are subject to the retention of information which should include the sign and dating of such data by the person responsible. Good documentation practices are expected to assure that all recorded data is accurate, legible and traceable. We all know that the FDA strongly believes “if it wasn’t documented, it didn’t happen”. FDA also wants to see how you document results. It’s also been observed that the lack of good GDP is consistently cited in FDA 483 observations. The training departments need to make GDP an integral part of every employee training.
Why You Should Attend:
A basic overview of good documentation practices will be covered in this webinar. It will also include examples of practices that not acceptable to auditors. A sure-fire way for auditors to find gaps in the quality unit processes is poor documentation practices. You must ensure documentation errors found must be corrected so that you are fulfilling the responsibilities for review of documents. This webinar will ensure attendees can review their own procedures confidently. It will also address what should be included in applicable training sessions for employees. The topics that are covered are important for activities ranging from the review of qualification protocols to the recording of information found in batch records and beyond.
Areas Covered in the Session :
- What is the definition of good documentation practices?
- Review of examples of good documentation practices and what they apply to
- Examples of documentation practices that should be avoided
- Review of practices for correcting mistakes or when space is limited for comments
- Review of FDA 483 citations give to companies
Who Should Attend:
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Research and Development Departments
- Engineering Departments
- Manufacturing Departments
- Validation Departments
- Management Teams