Pharmaceutical Data Integrity Success Training Kit - Pack of 8 Training Courses

Based on 8 webinars presented by experts with hands-on industry experience in both pharmaceutical and medical device manufacturing operations

Order this data integrity training kit to achieve compliance with regulators’ expectations without committing a disproportionate amount of human or financial resources.

You hear it all the time: companies receiving warning letters and being scrutinized for data integrity. They think they have taken all measures for data integrity and hope there are no issues.

Many of these companies - wish and hope, but still, run into data integrity issues.

Without the right understanding, proper controls, and tools, even your best efforts can go awry. On the other hand, when you have the right understanding of how to achieve data integrity and implement the right measures, you achieve data integrity and compliance.

Our comprehensive 'Pharmaceutical Data Integrity Success Training Kit' contains everything you need to guarantee data integrity success. It's the culmination of 50 plus years of combined experience packaged into one training kit we could share with you, and you can order your kit right now!

All Modules:

• Module 1: Pharmaceutical Data Integrity
• Module 2: Implementing a Robust Data Integrity Program
• Module 3: How to Detect Lack of Data Integrity
• Module 4: Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
• Module 5: Implementation and Management of GMP Data Integrity
• Module 6: Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience
• Module 7: Advanced Auditing for Data Integrity
• Module 8: Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
• Part 1 : Pharmaceutical Data Integrity
• Instructor: Mark Powell

Areas Covered in the Webinar:

• Data integrity myths
• Historical background
• Definition of data integrity
• Current regulatory approach
• Guidance
• Static and dynamic records
• Non-conformance trends
• Example enforcement letters
• Data integrity risks in the analytical process
• Conducting a data integrity risk assessment
• Common causes of data integrity breaches
• Practical tips on achieving compliance
• 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

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• 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

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?
• 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?
• Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further investigation.
• 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 : Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
• Instructor: Gregory Martin

Areas Covered in the Webinar:

What is meant by ‘Data Integrity’?

• Data integrity expectations from the FDA guidance
• Discussion on computer systems, notebooks and spreadsheets
• FDA warning letters citing data integrity issues
• Practical steps you can take to avoid being cited
• Questions and discussion
• Part 5 : 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 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
• Part 7 : Advanced Auditing for Data Integrity
• Instructor: Joy McElroy

Areas Covered in the Webinar:

• Applying consistent meta tags to all documents
• Applying consistent policies to all records
• Achieving a best practice level of compliance
• Centralizing management and eliminating silos
• Reduce compliance and e-discovery risks
• Building a better business case
• Part 8 : Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues
• Instructor: Gregory Martin

Areas Covered in the Webinar:

What is meant by ‘Data Integrity’?

• Data integrity expectations from the FDA guidance
• Discussion on computer systems, notebooks and spreadsheets
• FDA warning letters citing data integrity issues
• Practical steps you can take to avoid being cited
• Questions and discussion