Aidan Harrington to present paper to ISPE annual meeting in Atlanta this September
Dr. Aidan Harrington, Principal CQV & Regulatory Consultant with DPS, is to present a paper to the annual meeting of the International Society for Pharmaceutical Engineers in Atlanta, USA later this month.
Aidan will be presenting his paper on September 19th in the Facilities Design and Management Session and this will be the first time that a DPS executive will present a paper to the ISPE North American annual meeting, a major and prestigious event in the global pharmaceutical engineering industry’s calendar.
Aidan’s paper Introducing an Innovative Advanced Aseptic Filling Technology to a sterile manufacturing facility will provide an overview of the changing landscape for aseptic fill finish operations, presenting a novel advanced robotic multi-format filling line to be investigated for implementation in a new facility.
The paper will highlight the opportunity to eliminate humans from direct contact with the aseptic filling process. It will describe the journey undertaken to evaluate the technology; engagement with the diverse groups of stakeholders including the steps taken and challenges and hurdles encountered. It will present the outcome of peer group reviews, risk assessments.
According to Aidan: “I will discuss changing the mindset amongst the invested groups for implementation of new and innovative technologies, the regulatory challenges, opinions, conclusions and points of interest. I will present the outcome of our assessment and conclusions regarding the opportunity to implement such novel equipment with and make recommendations for peers undergoing a similar process with this or other innovative equipment.”
Aidan has worked in the pharmaceutical industry since 1992, working in QA, Validation and Engineering roles in both manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations.
Aidan has extensive regulatory inspection exposure experience, both FDA and HPRA (ex.IMB) and has played significant roles on the planning and implementation of Commissioning and Qualification programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to product Process Validation for aseptic manufacturing facilities.
Aidan offers consultancy to a range of clients in areas such as concept design for cGMP compliance, risk reviews, technology transfers and contamination investigations.
