Ready to Change the Way You Think About Engineering, Construction, & Operation?

I am pleased to be a part of the planning group that works to plan and develop content for the ISPE Aseptic Show. The group pours time and effort into discerning the leading trends, the upcoming innovations, and the regulatory issues that you will be experiencing in your production facility.

This year we are virtual. In some aspects, this is better for you in general. Presenters are recording their presentations beforehand and we will be answering questions live. You will have recordings for later. Have your questions ready. We are all excited to have more interactions. There are incredible topics that will be discussed.

The keynote will kick off on Monday, March 12 with a presentation and discussion on where the Pharmaceutical industry is heading; hear their perspective on how the COVID-19 crisis has changed the industry and their perspectives. The FDA will speak along with GSK and Pfizer.

ATMP products will be a hot topic and will have multiple sessions and speakers.

• Intersection of ATMPs and New Technologies: conversations about cleanrooms, isolators, manufacturing at clinical scale and at commercial scale, new equipment, innovations, and painful lessons learned. Flexibility is key. Plan now.
• Next Generation ATMP: defines where the industry is going and growing. Multimodal (do it all) facilities for that magic bullet cure, challenges, and solutions will be presented that will change the way you think about engineering, construction, and operation.
• Not the same old Topic will include a discussion about H2O2 Decontamination for both cleanrooms and isolators. This 30+-year-old technology is not the same technology and not the same uses as before. It is important to know the when and how testing should occur to not put your products at risk. Do not wait. Know when to test.

Handling Highly Hazardous (Potent) products while protecting the quality of your other products and your operators too is one of the most popular sets of topics. We have a group of presenters that are happy to talk about approach, equipment, and safety.

• Contamination and Cross Contamination Control for Bio Safety: Contamination and Cross contamination are often two different things. Do you know the difference? Manufacturing and safety approaches will be discussed to approach biological hazards and chemical hazards.
• Containment: Understanding Why, When, and What Regulatory Agencies Expect: It is no longer common to have a facility defined for only one product. How do you manufacture multiple drug products in one facility while making sure that any and each patient only gets the drug they were prescribed, not the one you made yesterday? You will discover that there are many that are using cross contamination control to protect patients…and operators. Design your facility correctly, design your equipment appropriately, monitor the spaces appropriately to protect each and every patient and each and every operator.

At the 2021 ISPE Aseptic Conference, understanding regulatory definitions, expectations, and implementations is key to why this show brings value to the entire industry. These topics are what we all look forward to. There are few places where you will be able to ask a regulatory inspector or a trainer of regulatory inspectors a question. You can at this event.

• Plenary Session – The revision of EU GMPs Annex 1: What impacts can we expect as an industry? There will be a panel of people to speak about the herculean effort underway currently to revise the draft version of Annex 1. Understand from this session the changes, the weaknesses, the concerns, and then strengths of the draft document that was issued.
• Interactive Regulatory Panel: Everyone’s favorite topics are centered around regulatory compliance. What will “THEY” be looking for when “THEY” audit my facility? “THEY” will be speaking in an interactive regulatory panel on Wednesday, March 17. This is the favorite event for everyone. It is a time to get questions answered and answers questioned. The panel does a great job discussing the risks that they see in the industry and how that affects their decisions on policy. CDER/FDA, PIC/s, ORA/FDA, FDA/C, TGA, and ANSM have been invited to be on the panel to speak about the current state and the future state of expectations in the industry.

I have written about a fraction of the topics that are planned for the 2021 ISPE Aseptic Conference: Setting the Pace for 30 Years! Aseptic practices, equipment, facility design, construction, Modular cleanrooms, robotics, QRM, tech transfer, single-use technologies, and more will be discussed. Come join us for our thirtieth-year celebration to hear about these topics and more.

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