GAMP® Data Integrity 21 CFR Part 11 Course Description
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.
Part 1 - The Keys to COTS Computer System Validation - 1 hr - 11 -12 PM EDT
Part 2 - Step-Wise Process for COTS Risk-Based Computer System Validation and Change Control - 1 hr - 12- 1 PM EDT
Break Working Lunch – Discussion and Q&A - 30 mins 01:00 - 01:30 PM EDT
Part 3 - 21 CFR Part 11 Compliance - 1 hr - 01:30 -2:30 PM EDT
Part 4 - Purchasing COTS Software - 1 hr - 02:30 - 03:30 PM EDT
Part 5 - Industry Best Practices - 1 hr - 03:30 - 04:30 PM EDT
Wrap- Up - Q/A - 30 minutes - 4:30 -05:00 PM EDT
What You Will Learn
This training 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
Who Will Benefit from Data Integrity Training
- 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.