MEP Eva Maydell opened the seminar: “Innovation in Medicine – ATMPs”
September 21-29, 2020
Location: Virtual
Virtual Meeting | Monday-Tuesday, 21-22 September 2020
Talks will focus on hot topics in GCP, GLP, GMP, Computer Validation, Pharmacovigilance and more, with special sessions related to SARS-CoV-2 (COVID-19). The virtual meeting offers up to 11.75 RQAP re-registration units for the total number of hours of content presented. RQAPs, please claim units for the number of hours you attend.
Quality College | Wednesday-Friday, 23-25 September 2020 and Monday-Tuesday, 28-29 September 2020
One-day and half-day courses on a variety of QA topics.
PharmaLex expert Gerardo Gomez PhD, Director of Validation Services, will present:
Maintaining the Validated State of your Equipment and Processes During the COVID-19 Pandemic to Ensure Continuous Product Supply
For the professionals that work at the Life Sciences Industries, and specifically in the manufacturing sector, the concepts of Validation and Change Management go hand in hand. Since 2011, the scope of Process Validation, as defined by the FDA in their “Guidance for Industry” published that year – includes essentially all activities that involve testing and/or verification of equipment, methods, systems, and processes necessary to manufacture a safe and effective medicinal product at commercial scale. In this guidance, the term “Process Validation” is also used to include those activities needed to assure that the much sought after and often difficult-to-reach validated state is maintained under “normal, steady state” conditions, even when changes or variations do not appear to be present.
But how do the present COVID-19 times change this expectation? What has changed during the first part of 2020 – or what could change in the near future – that poses a threat for companies to maintain the validated state of their equipment, systems, and processes?
In this presentation, the author will be discussing what has been the most common challenges faced by companies in the Life Sciences sector to not only validate their new equipment and new product/processes, but also to ensure a healthy product supply by maintaining the validated state at their manufacturing sites. The discussion and ideas presented will tie these new and very much real challenges to the Change Control and Investigation/CAPA Quality Systems while assessing the need and extent of requalification, including the timing scenarios for each one.
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