Implementing a Robust Data Integrity Program

In this webinar, learn how to develop a data integrity governance program, and the principles for defining quality and data integrity processes and systems. It will examine common issues from FDA 483 observations and explain how to prevent them.

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Sep-2019

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Fax: +1-650-362-2367

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

With the regulatory inspections increasing focus on data integrity, managers, supervisors, and users in regulated GMP laboratories must understand the problems related to data integrity and implement robust compliance programs. To ensure the integrity of data, it should be maintained to assure consistency, and accuracy over its complete life-cycle. Data integrity being a world-wide issue, both the FDA and the European regulatory agencies primarily focus on the topic during their regulatory inspections. Many FDA warning letters and EU GMP non-compliance reports provide evidence of major data integrity problems and falsification within organizations worldwide. Agencies such as FDA, EMA, MHRA, WHO, and PIC/S along with domestic and foreign governing agencies have responded to such concerns by publishing data integrity guidelines and standards.

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
  • 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.
Who Will Benefit:
  • Quality Assurance
  • Regulatory Affairs
  • Operations Managers
  • Speaker Profile
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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