The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Areas Covered

This training course will provide a practical understanding of the following:

• The current regulatory focus on Data Integrity, including a detailed discussion of US 21 CFR 11
• Relevant regulatory observations
• Current regulatory Guidance on Data Integrity (emphasizing MHRA and FDA)
• The need for Data integrity throughout the system and data life cycles
• Detailed examination of the data life cycle
• The requirement for a data governance framework
• A data integrity maturity model
• How to meet the international regulatory requirements for electronic records and signatures?
   - Detailed examination of specific requirements of 21 CFR 11 electronic records and signatures
   - How to satisfy Part 11, including interpretation of the FDA Scope and Application Guidance
   - How to meet the requirements of other relevant regulations including EU Annex 11
   - How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
• How to maintain Data Integrity through the GAMP system life cycle and beyond
• How cloud computing approaches can impact data integrity
• Data integrity and mobile apps
• Data mapping is an important tool in ensuring data integrity
• How to apply the new ISPE GAMP® Guide: Records and Data Integrity including: 
   - Data Governance Framework
   - Culture and Human Factors
   - Data Life Cycle
   - Applying Quality Risk Management to Data Integrity

Course Level - Fundamental / Intermediate

Who Should Attend

• Analytical Development
• Quality Assurance
• Quality Control
• Validation
• Regulatory Affairs