We are pleased to welcome you to the 7th Highly Potent Active Pharmaceutical Ingredients Online Summit.
This event will cover the most popular aspects on the HPAPI industry. We will overview the regulatory environment including facility requirements, while also discussing handling and containing. This is an opportunity for the HPAPI community to interact with each other, share their knowledge, and gain valuable insights from each other's work experience. The panel after each presentation gives you the ability to define and solve some of the questions that you might have.Read more
The Highly Potent Active Pharmaceutical Ingredients Online Summit is back with its 7th edition.
HPAPI manufacturing is a rapidly growing industry that presents important challenges to the production site. The health of the operators (OEL > 1mg/m3) and patients (fewer side effects) is the main priority for the businesses, as well as caring for the environment and rational optimisation at high containment facilities.
Join us and learn about the latest market development trends and safety perspectives on handling highly potent APIs and many other interesting topics, including how the contract manufacturing organisation (CMO/CDMO) works and the solutions for control, new regulatory compliance challenges in 2022, and more.
Chief Executives, Vice Presidents, Directors, Department Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Fellows, and Investigators specialising in:
Justin Mason-Home is an organic chemist with extensive health, safety, environmental, and chemical engineering experience in senior technical, legal, and commercial aspects of the pharmaceutical, biochemical, chemical, and other industries. He is a Fellow of the Royal Society of Chemistry in the United Kingdom.
Justin started as a research chemist in the flavour and fragrance sector, researching and discovering new chemical synthetic routes to produce nature-identical flavour and fragrance components. In the fine chemical sector, he worked through scale-up (Kilo Lab then Pilot Plant) to full-scale manufacture. After a move to corporate environmental management, Justin was head-hunted into environmental consulting, heading a technical environmental engineering function.
He has since held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, he's held a board level position in a biotechnology company, and has worked in corporate environmental management. Justin has been involved in and worked on potent and highly-potent API projects for more than 22 years and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly-potent and toxic biopharmaceutical compound matters. Justin has chaired, presented at, and attended many HPAPI events and is a recognised expert in this area.
Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert containment group of the ISPE DACH eight years ago. The containment group published the containment manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.
Dr. Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development department of the pharmaceutical business unit of Bayer.
He is responsible for the release of chemical APIs for clinical trials, the GMP-quality system, and the QA-oversight of the pilot plants and analytical development laboratories.
Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany.
He has about 20 years of industrial experience at Bayer AG in different QC/QA-functions and two years' post-doc experience at Novartis in Switzerland.
He is and was involved in many technical (transfer) projects as well as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept for the chemical development department.
Jack Brown was raised in Idaho (USA) and earned a BS and PhD in chemistry at Utah State University in Logan, Utah. He continued studies under the direction of Professor Albert I. Meyers at Colorado State University in Fort Collins, Colorado. Jack started his professional career at Syntex Chemicals, as a principle scientist followed by working for Hoffmann La Roche, until 2002, and rose to the rank of distinguished scientist while working on multiple projects, such as Naproxen®, Saquinavir®, and Tamiflu®. In 2002, he moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia, as the manager of process chemistry and stayed there until 2014. From 2014-19 he worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, as a principle research scientist and retired in September 2019 as a senior research fellow. Recently, he was elected to the vice chair of the Virginia section of the American Chemical Society and has been consulting in the areas of process safety, HPAPIs, and process development.
Silke Büchl is an experienced IOHA certified occupational hygienist with about 20 years of experience in occupational hygiene.
She became an IOHA certified occupational hygienist after her postgraduate studies for work and health at ETH Zürich and Uni Lausanne in 2003.
Before she started as an occupational hygienist and deputy of the managing director at Praevena in 2014, she gained experiences in different fields of occupational hygiene, safety data sheets, hazard communication with the focus on occupational hygiene topics as well as participation in the internal board to define occupational exposure limits at Novartis.
Praevena is a company that provides services such as: Exposure monitoring with regards to occupational hygiene and SMEPAC, customised training, customised concepts (PPE, work processes, OEL classification, etc.), workplace health risk assessment, performing quantitative fit testing.
Hermann Schmidt studied process technology and bioprocess engineering at the University of Applied Sciences in Nuremberg, Germany, and works as operations director of the pharma and lab division at HOSOKAWA ALPINE AG in Augsburg, Germany. He has been working in the field of powder handling and grinding of pharmaceutical products for more than 30 years and has extensive experience with various aspects of GMP and containment production subjects. His experience ranges from smallest R&D systems to multi-ton cell culture media plants including powder handling, containment, cleaning, and sterile processes.
Stefano Butti studied mechanical engineering at University of Milan and graduated in 2000. An ISPE member since 2002, he participated as a speaker at different events on containment and micronisation both for HPAPI and sterile application as well as published different articles in technical newspapers.
Stefano worked as a project and process manager in the chemical and pharmaceutical business following containment and micronisation system installation worldwide. He also took a direct role in the definition of containment system upgrade and optimisation for the handling of products with OEL down to ng level with successful results. Additionally, Stefano has worked on a few projects where a combination of sterile and toxic compound handling was successfully coordinated.
He joined FPS in 2008 starting as a technical sales manager and he is now head of the sales group for the company's containment and micronisation system provided worldwide.
Thomas Weingartner is the managing director of Lugaia Deutschland GmbH. Previously he held managerial positions in powder handling companies and has been active in the field of containment for more than 20 years. Thomas develops customer-specific containment solutions on the basis of high-quality film materials. His experience includes pharmaceutical industrial hygiene and safety for other industries such as life science and fine chemistry. Thomas has a wealth of experience in providing and installing containment solutions to minimize the risk of contamination.
The core competence of Lugaia lies in the market-ready products based on film, which customers use as single-use solutions in hygiene process technology. The film systems manufactured in clean rooms are used once and then disposed of. This eliminates the need for expensive and time-consuming cleaning processes for the systems and the costly qualification procedures that go with them.
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Interesting webinar with reasonable price including questions and answers option. In the future I would like to hear more about environmental controls and efficiency, please.
Looking forward to attending to the next addition! Thank you
I found online addition of the 6th HPAPI Summit convenient to me. It was quite informative and enjoyable. Also, I liked Justin’s moderation skills! Thank you to the organizers
The varies geography of the speakers was appropriate to me as I work between USA and the EMEA. looking forward to the next edition.
Oct 2, 2019
5th Annual Highly Potent Active Pharmaceutical Ingredients Summit