Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

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

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

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

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

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

Wrap Up and Review

• Attendees have time to ask any final questions for the day

Adjournment of Day One

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

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

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

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

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

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

Wrap Up and Review

• Attendees have time to ask any final questions for the day

Adjournment of Day Two