Director Product Development at Novatek International
Susan Cleary, B.Cs, EMBA. is the director of product development at Novatek International. Susan has more than 20 years of experience in designing, developing, and implementing
large-scale quality management and contamination control systems. Susan works with pharmaceutical, biotech, and medical device companies and specialises in data integrity and
regulatory compliance. She is highly experienced working with clients to streamline their procedures and digitise their data
Fri. February 24 | 11.00am – Pattern Recognition and Trending for Regulatory Compliancy and Contamination Control Strategy
The regulations are evolving, for example EMA Annex 1, earlier versions did not mention trends, the current draft version mentions it 23 times. WHO, and FDA also talk about trending, root cause analysis, investigation, and using the data for these purposes. PDA technical report 13, the new revision, even states that automation for data management for environmental mentoring is “essential”. Trending the data is now a regulatory requirement but what trends should we use, and when?
The last 20 years we have been collecting data and regulations like Annex 11/21 CFR part 11, and more recently the data integrity guidelines, have facilitated security and confidence the data is accurate and reliable. Now this regulatory evolution is mandating the use of the data for the betterment of our processes, process control, product quality and patient safety.
The presentation will include a review of key regulations as they relate to the need to use the data collected for trending, process control, investigation, and root cause analysis.
The digitization is still in process, pharma industry due to the regulatory scrutiny are sometimes late adopters but the need to digitize is ever more important based on the evolution of the regulations encouraging trending and using data.
Discussion will then cover the key contamination control processes including pharmaceutical water, HAVC, and gas monitoring, as well as environmental and personnel monitoring, also touching on cleaning validation and cleaning process monitoring.
The lion share of the talk time will relate to the different trending tools, when they should be used, and what they mean.
Examples of trends will be included in the presentation.
A discussion about the critical properties which should be tracked, including media, shift, equipment, surface type, and others is included and will lead into data review for pattern recognition.
The conclusion will restate the need to digitize to help control the processes and to meet regulatory compliance for data integrity, trending, and ultimately to enhance product quality.