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.
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:
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.
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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.
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