Why should someone attend this conference?
The ISPE Aseptic Conference is considered one of the most complete technical and regulatory-focused conferences in the industry because it brings forward case studies, new technologies, and regulators together in rooms to talk about concepts that are key to delivering safe aseptic and sterile products to the industry. The time spent in the training sessions, in the questions and answer sessions, and in the expo hall is high-value time due to the fact that innovation, quality improvements, and cost savings that can be discovered and planned in a matter of two days.
What are you most looking forward to?
There are really two big things that I am looking forward to: The regulatory panel and the industry panel. The ISPE Aseptic Conference is known for the regulatory panel that happens on the second day. Attendees can pose questions to the US Food and Drug Administration (FDA) to answer. Over the years, this session has had great impact on operations companies as they prepare for their regulatory compliance reviews with the US FDA, EMA, and others.
The other item that always delivers incredible technical learnings is the industry panel: it is a highly diverse panel that addresses hot topics for the production of aseptic and sterile products. Each year, the panelists bring more and more depth to the discussion by bringing the newest and most complex issues to the forefront: transfers of sterile materials, training of personnel, ease of changeover, and improvements in operation are all big topics this year.
Any advice for someone to make the most out of the conference?
To make the most out of the conference, my suggestion is that you show up early and attend the Aseptic 101 event on Sunday night before the conference. Attending can help solidify your terminology and allow you to meet students, meet subject matter experts (SMEs) in the industry, and start to create your network of mentors. If it takes a village to raise a child, it takes partnerships across the entire industry to operate and improve aseptic manufacturing.
Why do you think professional development is important?
Professional development is extremely important to maintain current GMP. One of the most dangerous groups in an organization is one that is stagnant and non-improving. Professional development is one of the most important levers to pull to create an involved, empowered, continuous improvement organization. Quality, as per ICH Q10, is not supposed to be a stagnant, controlled environment. It is supposed to be ever-improving and ever-evolving. The US FDA, EMA, and others are calling for more improvements for methods, training, and data management every year. It will take professional development and exposure to committed people with different experiences in order to continue improvement in operations.
Professional development is extremely important to maintain current GMP.
Why did you volunteer to be a conference chair?
I am a big believer in giving back to the organizations that have served my growth, and I know without a doubt that by serving within ISPE, I gain more than I give—no matter how much I give. The group serving as the Aseptic Conference Planning Committee is one of the most incredible groups of people that you will ever meet. By working with these individuals across the planning year, I learn more and more about the industry, conference planning, and individuals. I gain a great deal from being around them along the way.
Why do you enjoy being a member of ISPE?
ISPE provides an environment that allows for continuous learning. There are ample resources and opportunities to pick up on the leading edge of industry changes and expectations. I utilize discussion forums, Pharmaceutical Engineering® magazine, communities of practice, Baseline Guides, and several of the conferences to stay up to date on technological advancements and changes in regulatory expectations.
After many years of investing time and effort into helping ISPE, I have also found that it allows me the time and places to meet new people and build my community. The network of resources becomes highly valuable when obscure questions around operations and regulations occur. It is fantastic to be able to reach out to a community of well-trained people and find the best answer for the situation. Without ISPE, a lot of time could be spent to come up with appropriate answers.
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