The importance and amount of data being generated to ensure product quality and patient safety continue 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. 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 for 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
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 for 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
Who Will Benefit:-
Analytical Development
Quality Assurance
Quality Control
Validation
Regulatory Affairs
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