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 questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical 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 classroom course will provide a practical understanding of the following:
- The current regulatory focus on Data Integrity
- Relevant regulatory observations
- Recent regulatory Guidance on Data Integrity
- The need for Data integrity throughout the system and data life cycles
- The requirement for a data governance framework
- How to meet the international regulatory requirements for electronic records and signatures
- How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the 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 operation phase of the GAMP life cycle
- How new technologies such as cloud computing and mobile applications can impact 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
It is recommended that course participants have a basic awareness of GxP regulations and/or the use of computerized systems in a regulated environment. Some knowledge of the GAMP approach to computerized systems compliance would be an advantage.
- Data Integrity through the Lifecycle
- MHRA Data Integrity Guidance
- Regulatory Citations for Data Integrity
- Data Governance
- EU Annex 11 and Chapter 4
- Compliant Operation of GxP Regulated Systems
- 21 CFR Part 11 Electronic Records and Signatures
- Data Integrity for Spreadsheets
- Mobile Devices and Cloud Computing
- ISPE GAMP Guide on Record and Data Integrity
Take Back to Your Job
- Understand the current regulatory focus on Data Integrity and the relevant regulatory observations
- Review the new MHRA Guidance on Data Integrity
- Analyze the need for Data Integrity throughout the life cycle
- Evaluate the requirements for a robust data governance system
- Know how to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the USFDA interpretation in the Scope and Application Guidance, and international regulatory requirements for electronic records and signatures including Annex 11
- Apply the current industry risk-based good practice approach to compliant electronic records and signatures
- Understand approaches to cloud computing and mobile applications in the GxP environment
- Understand the Key Concepts and approaches of the ISPE GAMP Guide on Record and Data Integrity
Attendance Suggested for:
All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.
Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.
Computer system vendors or consultants, engineering contractors, and validation service companies.
Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the GAMP®Communities of Practice (COP).