Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
Clarifies how digital documentation can support DHF, DMR, DHR, batch record, and MDR technical file control across regulated device operations.
GROUP SAVINGS: Get your team to attend for just $390.
Individual registrations available too.
Batch documentation now sits inside broader data integrity expectations.
Device documentation choices now affect design control, technical file readiness, version control, audit response, and data integrity across global device operations.
This session structures the relationships among DHF, DMR, DHR, batch records, ISO 13485 files, and EU MDR technical documentation expectations.
The session moves from regulatory documentation purpose to expected contents, maintenance points, digital record advantages, and inspection focus. It compares FDA and Notified Body review priorities while keeping attention on practical file structure, record control, updates, and cross-functional ownership.
DHF, DMR, DHR, and MDR file boundaries under FDA and EU expectations
- Digital and electronic batch record expectations
- FDA DHF requirements and derivative records
- EU MDR technical documentation contents
- ISO 13485 7.3 design and development files
- DMR, DHR, lot, and batch record relationships
- General Safety and Performance Requirements matrix use
- FDA and Notified Body audit focus
- Manual versus digital documentation tradeoffs
Designed for professionals responsible for regulated device documentation, product files, record control, audits, and quality system execution.
John E. Lincoln
John E. Lincoln brings over 40 years of FDA-regulated industry experience, including extensive work in quality systems, design control, DHF remediation, technical files, software validation, risk management, and regulatory responses. His consulting background across device companies and global markets directly aligns with this session’s focus on FDA, ISO, and EU documentation expectations.
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Customized training is also available through TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
TalkFDA Elite Training Labs