FDA Data Integrity Training: Pack of 6 Training Courses

In today's strict regulatory environment, it is more important than ever for companies and individuals to understand and apply good data integrity practices to comply with FDA regulatory requirements and the new draft guidance. Data Integrity has become one of the hot topics during audits and inspections in the FDA Regulated industry.

Not only does data integrity compliance safeguard patient safety, but also protects the organization from serious financial consequences of FDA's enforcement action. These consequences may include facility shutdown, product recalls, import and/or distribution bans, delayed or denied drug approvals, substantial remediation costs, and loss of customers due to a damaged reputation. Data is the fuel of decision making, continuous improvement, quality, and demonstration of clinical value.

Help yourself and your organization to keep your data consistent, complete, and accurate throughout the data lifecycle by ordering this training kit today.

These courses will provide the fundamentals of how to build a robust data governance system that will help keep your data consistent, complete, and accurate throughout the data lifecycle

All Modules:

Module 1: Implementation and Management of GMP Data Integrity
Module 2: Implementing a Robust Data Integrity Program
Module 3: How to Detect Lack of Data Integrity
Module 4: FDA Compliance and Enforcement Trends focused on Data Integrity
Module 5: Data Integrity Compliance for Computer Systems Regulated by FDA
Module 6: Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Part 1 : Implementation and Management of GMP Data Integrity
Instructor: Danielle DeLucy

Areas Covered in the Webinar:

• Understand the current regulatory position on data integrity
• Discover the criteria for data integrity
• Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
• Learn about approaches to improve data integrity in a laboratory environment
• Part 11 compliance
• FDA citations related to data integrity issues

Part 2 : Implementing a Robust Data Integrity Program
Instructor: Kelly Thomas

Areas Covered in the Webinar:

• Topic 1: Regulatory Guidance Review
• FDA (CFR)
• EU (EurdraLex)
• PIC/S
• Topic 2: Review all Elements Important to Maintaining Data Integrity
• The ALCOA+ criteria for data integrity
• Data life cycle in the process workflow – managing controls
• Paper versus electronic systems
• Validation of computerized systems for data integrity controls
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Topic 3: Key Data Integrity Topics
• Recording results on paper. Good Documentation Practices
• Audit trail
• Data review
• File format
• Storage media
• Encryption
• User management (access control)
• Review of the data life cycle
• Handling of raw data
• Unauthorized access
• Appropriate access privileges for each user role
• Is my chromatographic system ready? Role of “test” injections
• Audit trails – options for older systems
• Manual chromatographic integration
• Standalone versus network systems
• Protecting electronic records of standalone systems
Topic 4: What are GMP-relevant Data?
• GMP-relevant data – what are GMP-relevant data?
• Identifying data that has been changed or modified – how the system can help
• Review by exception – how technical controls can help
• Have you specified and validated these functions?
Topic 5: Why Is An Audit Trail Review Important?
• Suspected data integrity violation - What do we need to do?
Topic 6: Can Spreadsheets meet Data Integrity requirements?
• Problems with spreadsheets
• Good Practice for using spreadsheets in a regulated environment
• Building data integrity features into a spreadsheet
Topic 7: Common problems from FDA 483 observations and warning letters and how to avoid them
• Case Study 1: Audit Trail to Review?
1. Attendees will be presented with an overview of the audit trails within an application and the content of each one. Which audit trails should be reviewed and when?
2. Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further investigation.
3. Attendees will be presented with a list of records to identify if they are GMP records. Examples from production, laboratory and QA examples of GMP-relevant data will be provided.

Part 3 : How to Detect Lack of Data Integrity
Instructor: Ron Snee

Areas Covered in the Webinar:

• What is data integrity; what does it look like
• Case studies illustrating types and sources of data integrity issues
• Procedures for assessing data pedigree, integrity and quality
• Data Pedigree – A New Tool for Assessing the Level of Data Integrity
• Computer, analytical and statistical methods for evaluating data integrity and quality
• Limitations of observational data
• Guiding principles, tips and traps for the effective data integrity assessment

Part 4 : FDA Compliance and Enforcement Trends focused on Data Integrity
Instructor: Carolyn Troiano

Areas Covered in the Webinar:

• Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Learn about the importance of doing a risk assessment of all FDA-regulated systems
• Learn about the importance of categorizing your FDA-regulated software according to GAMP 5 guidelines
• Understand “GxP” Systems
• Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Learn how Data Archival plays a key role in ensuring security, integrity and compliance
• Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
• Learn about recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11 and data integrity
• Understand the latest guidance from FDA on data integrity
• Learn about recent trends in technology that need to be addressed in the CSV approach
• Learn about industry best practices for becoming inspection ready
• Q&A

Part 5 : Data Integrity Compliance for Computer Systems Regulated by FDA
Instructor: Carolyn Troiano

Areas Covered in the Webinar:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Data Integrity (DI)
• Validation Strategy, Planning and Execution
• System Risk Assessment
• GAMP 5 “V” Model and Software Categorization
• 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
• Security, Access, Change Control and Audit Trail
• Criteria required to ensure data is created and maintained with integrity through its life cycle
• Policies and Procedures to support CSV and DI assurance
• Training and Organizational Change Management
• Current FDA Trends in Compliance and Enforcement
• Industry Best Practices and Common Pitfalls
• Q&A

Part 6 : Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
Instructor: John R Godshalk

Areas Covered in the Webinar:

• What is data integrity?
• What are the relevant regulations for data integrity?
• Why record data and create records?
• What is the interaction with software and data integrity?
• What documentation/evidence does FDA look for during an inspection with regard to data integrity?
• Examples of Data Integrity issues: data integrity and the pre-approval inspection, data integrity in the lab, data integrity in the batch record, computer systems, data falsification, importance of audits
• Summary/ Q&A

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