Data Integrity and Good Documentation Practices (COM)
At
Six Seasons Hotel
For more information: https://www.eventbrite.com/e/data-integrity-and-good-documentation-practices-com-tickets-43749413674?aff=RMV
DESCRIPTION
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Data Integrity and Good Documentation Practices
Two interactive modules that tackle the both the requirement and the discipline needed to consistently document the manufacturing and testing of APIs, Formulations and Vaccines:
warford-reaney
FDA: Expectations for Data Integrity Ethics, Law and Transparency
Data Integrity Reality: Find; Panic; Investigate; Report and Repair
Culture, Ethics, Human Error and GMP Compliance Challenges
Documentation Best Practices
Learning Objectives:
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Regulatory Expectations and Laws regarding Data Integrity
How to handle Data Integrity challenges of detection, investigation, regulatory response and CAPA
Case Studies that describe real life examples of how companies have handled Data Integrity Issues and how the regulators reacted
Understanding the process and cultural Root Causes for Human Errors and how to reduce them
Best Practices for creating GMP appropriate Documentation
How to encourage GMP Documentation discipline on the shop floor, warehouse and labs
How the interactive role of the quality systems and plant management can bring about a culture of good GMP documentation
For more information: https://www.eventbrite.com/e/data-integrity-and-good-documentation-practices-com-tickets-43749413674?aff=RMV
Who will Benefit:
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QA Personnel
IPQA Personnel
QC Personnel
Manufacturing Personnel
Warehouse / Material Management Personnel
GMP Management Personnel
R&D Personnel involved with Tech Transfer
GMP API Personnel
Non-GMP Intermediates Personnel
CRAMS Personnel
HR Personnel
SPEAKER
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Warford Reaney
Warford Reaney
Consultant and Mentor
Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges.
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/data-integrity-and-good-documentation-practices-com-tickets-43749413674?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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