Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity

How the use of digital/electronic versions of US FDA's and EU's  DHF, DMR, DHR, and the EU's MDR Technical Documents Files / equivalents Can reduce the possibility of delays in implementation/ changes  and chances of human error in use, while maintaining data integrity. 

A popular seminar, updated with the latest FDA and EU requirements and newer digital / electronic tools. As U.S. companies go global, they must meet different product design documentation.  The cGMP's mandate Design Control and the Design History File (DHF).  ISO 13485 mandates the same, a Design and Development File, per 7.3, which is now to be part of the EU's MDR-required documentation. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical Documentation FiIe.  Currently they serve different purposes, support different goals, but their roles do overlap.  And how / where do the DMF and Batch Records fit?   Newer incorporation of digital formats in lieu of the old paper / legacy systems has the promise of increasing documentation accuracy and data integrity, through implementation, updates / revision, changes, and even decommissioning.  Regulatory accuracy, compliance and consistency is better assured as well.

| WHY YOU SHOULD ATTEND

This seminar will examine the existing requirements for the US  FDA's DHF, and the derivative documents, the DMR/F and DHR/batch records, the pros(and some cases) of digital / electronic alternative, and the identical ISO 13485 7.3 D&DF.  It will consider the EU's revised MDR and it's Technical Documentation File requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed.  Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends;  Typical DHF Table of Contents;  Technical Document File Table of Contents;  The importance and usefulness of the old "Essential Requirements", now "General Safety and Performance Requirements" and a suggested matrix format;  Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Additional benefits from digital records, e.g.,  Simplifying version control;  Streamlining template review and approval;  Improving data accuracy; increasing accessibility; and the easy ability to scale. t. Finally, the differing approaches to file inspections / audits by the FDA and Notified Bodies will be discussed.

| AREAS COVERED

• Digital / Electronic Batch Records; FDA Expectations
• The U.S. FDA's DHF;  EU's MDR and Technical Documentation 
• Design Control vs. a Product 'Snapshot in Time'
• DHF "Typical" Contents
• The DMR and DHR / Lot / Batch Record
• Technical File Expected Contents
• Focus on the General Safety and Performance Requirements and Why
• Parallel Approaches to Documentation -- Teams
• FDA and NB Audit Focus
• Risk Management and Human Factors Engineering
• Manual vs Digital Advantages / Disadvantages

| WHO SHOULD ATTEND

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Senior Management in Devices, and Combination Products

Course Director: John E. Lincoln

John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He is a peer reviewed, author, teacher and speaker.   John is a graduate of UCLA.