To achieve and remain compliant with the adequate use of the Excel spreadsheet in FDA-regulated environments, it is critical that laboratory personnel and managers including IT professionals understand and accurately interpret the applicable requirements. This is necessary to ensure compliance to Excel spreadsheets is sustainably demonstrated and achieved.
This webinar will discuss the adequate application (use) of Excel spreadsheets, which are frequently used in FDA regulated environments. You will understand how to use Excel spreadsheets, if and when required, in compliance with the list of requirements for the firm’s practices under 21 CFR Good Laboratory Practice (GLP), Good Clinical Practice, Good Manufacturing Practices (21 CFR Parts 210, 211, 820), 21 CFR Part 11 (Electronic Records), etc.
You will gain awareness of the following citations in FDA’s enforcement actions (e.g., FDA warning letters) including 483s which firms should be aware of:
- The Excel spreadsheets – neither controlled nor protected from modifications or deletion.
- An Excel spreadsheet has not been qualified.
- Excel spreadsheets are Non-qualified and uncontrolled.
- The use of an Excel spreadsheet was not validated by your firm.
- This session will provide you with great opportunities as quality and regulatory managers to become actionably familiar with the regulatory requirements applicable to Excel spreadsheets.
Areas Covered in the Session :
- Applicable Regulations and Definitions
- Applicable Regulations for Medical Devices
- 21 CFR Part 11
- FDA Guidance: Relevant and Applicable
- Common Problems in 483s related to Excel Spreadsheets
- Leading Causes of Common Problems in Excel Spreadsheets
- Regulatory Requirements Applicable to the Excel Spreadsheet
- Use of Excel Spreadsheets in FDA-Regulated Environment: Common Problems
- What to Do for Excel?
- Excel Validation – Documentation
- FDA Checklist for Excel Document for Consideration
- FDA Warning Letters
- Excel Data Validation
- Excel Data Validation: Input Message/ Error Alert
- Excel Functions for Protection
- Protecting the Worksheet
- Be Aware of Excel’s Limited Functions
- Best Practices: Dos and Don’ts
- Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Who Should Attend:
- Compliance Officers
- Regulatory Affairs Personnel
- Clinical Affairs Personnel
- Quality Assurance Personnel
- Laboratory Personnel
- IT Professionals
- R&D Professionals
- Any professionals interested in this topic
Course Director: DR. DAVID LIM
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.