Day 1 – Tuesday, April 19, 2022
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10:00 - 10:30 |
Welcome, Verification of Attendee Workshop Tools, Session Overview
- Review of connectivity and interactive tools
- Session agenda overview
- What to do in case of connectivity issues
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10:30 - 11:30 |
GMP and QSR Data Integrity – Requirements and Realities
- Core regulatory requirements – regulatory health agencies
- Practical elements of data integrity characteristics (ALCOA+) – how this looks in the “real-world” of raw materials/component intake, manufacturing, quality control sampling, and finished product distribution
- Overlooked guidance documents that can help define expectations (including what FDA and EMA inspect for and why)
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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11:30 - 12:00 |
Morning Break (offline) |
12:00 - 12:30 |
Post-Market and Complaint Handling Data Integrity Requirements
- Core regulatory requirements – regulatory health agencies
- Practical elements of data integrity characteristics (ALCOA+) – how this looks in the “real-world” of complaint handling, post-market reporting, recall handling and reporting, and product complaint trending
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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12:30 - 1:30 |
Lunch (offline) |
1:30 - 2:30 |
Suppliers and Data Integrity
- Accountability v. responsibility (the legal view)
- Data integrity chain-of-custody from raw material/component suppliers through your finished product distribution chain
- Digital data record keeping challenges for manufacturing and post- market/complaint handling data
- Typical supply chain red flags for data integrity that FDA and other regulatory health agencies look for
- Dealing with critical suppliers who collect, handle and store manufacturing and post-market/complaint digital data who are NOT regulated themselves
- Qualifying record/archival storage vendors (e.g., Iron Mountain, et al)
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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2:30 - 3:00 |
Afternoon Break (offline) |
3:00 - 4:00 |
Risk-Based Data Integrity Controls
- Basics of computerized system assurance as a risk-based approach
- Eight practical elements of data integrity (ALCOA+ in practice)
- How to narrow the scope to avoid doing too much
- Policies and SOPs to consider
- Site data integrity master plan
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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4:00 - 4:30 |
Wrap Up and Review
- Attendees have time to ask any final questions for the day
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4:30 |
Adjournment of Day One |
Day 2 – Thursday, April 21, 2022
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10:00 - 10:30 |
Welcome, Verification of Attendee Workshop Tools, Session Overview
- Review of connectivity and interactive tools
- Session agenda overview
- What to do in case of connectivity issues
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10:30 - 11:00 |
GMP and QSR Data Integrity Enforcement
- Examples and statistics from regulatory agencies
- Recent, relevant enforcement examples
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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11:00 - 11:30 |
Morning Break (offline) |
11:30 - 12:30 |
Digital Data Integrity Inspectional Tactics – Onsite v Remote
- Differences and similarities between the NIPP and remote inspection methodologies
- Example regulatory agency inspection questions to prepare for
- Example regulatory agency tactics during manufacturing and post- market/complaint handling inspections
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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12:30 - 1:30 |
Lunch (offline) |
1:30 - 2:30 |
Modern, Risk-Based Validation Techniques
- Validation by risk level – it’s all about the data
- Sampling and test cases – FDA’s view
- FDA’s view of supplier-provided validations
- Taking advantage of the traditional DQ\IQ\OQ\PQ format
- Example FDA-“approved” test cases for data integrity-based validation
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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2:30 - 3:00 |
Afternoon Break (offline) |
3:00 - 3:30 |
Data Integrity, Recordkeeping and Long-Term Archival Controls
- Records to retain to prove good data integrity controls
- Basics of bit rot and other risks to archived data
- Incorporating quality audits and sampling techniques
- Developing a media migration strategy
- Qualifying record/archival storage vendors
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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3:30 - 4:00 |
True and Certified Copies with Digital Records – Risks and Realities
- Basics of the true/certified copy and legal admissibility
- True copy requirements from submission guidances
- Putting together a true-copy scanning process for manufacturing records
- Interactive Q&A on this section - Attendees have the chance to ask questions and have them answered by the instructor
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4:00 - 4:30 |
Wrap Up and Review
- Attendees have time to ask any final questions for the day
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4:30 |
Adjournment of Day Two |