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Cleaning Validation & HPAPI Manufacturing Summit

  • 11th – 12th October 2022
  • Germany flag Germany Munich
  • Holiday Inn Munich - City Centre Hochstraße 3, 81669 Munich

This October we will bring together a dense variety of topics that will shed a light on the current situation in the world of cleaning validation and highly potent APIs manufacturing.  

The two-day summit will gather many experts from the fields that go hand-in-hand with each other. We will reach all the aspects that are needed to stay up-to-date, informed, and prepared for challenges in the coming year and beyond. 

If you want to improve your knowledge and expand your network, then the Cleaning Validation & HPAPI Manufacturing Summit is a great opportunity for communication with the pharmaceutical community. 

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About the Cleaning Validation & HPAPI Manufacturing Summit 

 

Day 1, October 11, 2022 – 5th Cleaning Validation  

The first part of the summit will be presented by market leaders, industry regulators, and manufacturers, who will share the critical conditions and case studies for an effective and most efficient cleaning validation program. 

Igor Gorsky, US - Chairman - Use of risk management in cleaning validation

Thomas Hauser, DE - Prefabricated cleanroom PODs as part of the facility of the future

Walid El Azab, BE - Improving cleaning performance 

Andrew Walsh, US - Quantitative measurement of risk in cleaning using ASTM standards 

Sunil Patel, US - Key benefits of a digitised cleaning validation program

Yossi Shapira, IL - Correct lyophilizer CIP, design 

Thomas Altmann, DE - Cleaning process development for HPAPI molecules 

Dr. Georg Sindelar, DE - Increasing inspection resilience – SME audit coaching on complicated topics

Susan B. Cleary, CA - Risk-based cleaning validation - Key elements for success

Dr. Martin Kohan, UK  - Permissible daily exposures (PDE) for cleaning validation

 

Day 2, October 12, 2022 – 8th HPAPI Manufacturing  

In the second part, we are moving to the manufacturing and handling of highly potent APIs. The rapidly growing industry is always dealing with many challenges from the health of operators to patient safety. We will define new regulatory compliance, care for the environment, rational optimisation at high containment facilities, and more. 

Justin Mason-Home, FRSC, UK – Chairman - Commercial matters within HPAPI projects – from due diligence to CMO relationships 

Richard Denk, CH - Trends on containment and outlook 

Yossi Shapira, IL - High potent drugs and product extraction/contamination and exposure while freeze drying process, and its unloading 

Dr. Thomas Adam, DE - HPAPI handling from lab bench to pilot plant (case studies) 

Igor Gorsky, US - Cross-contamination controls using USP <800> as a source for potent compound design of the facility

Steve Marnach, BE - Garment selection criteria for the safe handling of HPAPI

Dr. Friederike Hermann, CH  -  Maintenance of HPAPI small-scale production facility

Thomas Weingartner, DE - Lugaia containment solutions

 

Who Should Attend 

Executives, Directors, Heads, Leaders, Managers, Specialists, Engineers Professionals in Pharmaceuticals, Principal Scientists, Principal Toxicologists, QC Laboratories, Manufacturers of Drug Substances (APIs), Contract Laboratories, Oral Solid Dosage Form, Clinical Research Org., Contract Research Org., Contract Manufacturing Org., Biopharma Companies, Biotechnology Prod., and Fellows specialising in:  

  • Cleaning Validation  
  • Aseptic Processing  
  • Chemistry  
  • External Supply  
  • Continuous Processing 
  • Compliance 
  • Manufacturing Science & Technology  
  • Regulatory Affairs  
  • Business Development  
  • Commercialization 
  • Quality Assurance/Control 
  • Packaging 
  • Licensing 
  • Formulation Development  
  • Industrial Hygiene  
  • Health, Safety & Environment (HSE)  
  • Occupational Toxicology  
  • Corporate Toxicology   
  • Research & Development  
  • Process Development 
  • Strategic Development   
  • Risk Management  
  • Pharmaceuticals  
  • Biotechnology  
  • Plant Management 
  • Operations  
  • New Products 
  • Product Quality  
  • Drug Safety Evaluation   
  • Process Monitoring & Control  
  • Analytical Development Laboratories  
  • Internal & External Audit  
  • Training Departments  
  • Engineering  
  • Sterilization 
  • Vaccines 
  • Validation  
  • Production 
  • EHS  
  • QA/QC  
  • CMC  
  • CMO /CDMO 
  • Technology Transfer  
  • Other 

Key Practical Learning Points

  • Introduction of the brand-new ISPE Containment Good Practice Guide
  • Revision to ASTM E3106 and ASTM E3263
  • EMA Q&A Nos. 7 and 8 on HBEL guidance
  • GMP compliance and regulatory landscape
  • The Shirokizawa Matrix
  • The quantitative scales of toxicity, process capability, and detectability
  • Importance of lab testing and equipment design
  • 2x typical CIP systems design within lyophilizers
  • CIP validation principles and process monitoring, recording
  • The cleaning assurance level (CAL)
  • Solubility considerations for lab testing
  • Excipient considerations concerning cleanability
  • Process equipment special design for HPAPI containment system integration
  • Managing the CMO/CDMO relationship
  • Contamination during API and during drug products freeze drying
  • Micronisation of HPAPIs

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Richard Denk 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, and eight years ago he founded the expert containment group of the ISPE DACH. 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.

Igor Gorsky, US

Principal Process Validation Consultant

ValSource Inc.

Igor Gorsky has been a pharmaceutical, biopharmaceutical, and medical device industry professional for over 39 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth, and Shire. He worked in production, quality assurance, technical services, and validation, including as an associate director of global pharmaceutical technology, at Shire, where he oversaw global validation efforts, including analytical methodology, equipment and facilities qualification, process, packaging, shipping, computer and cleaning validation, and environmental monitoring programs. He is currently a senior consultant at ValSource, LLC. Over the years, his accomplishments include validation of all the aspects of pharmaceutical, biotechnology, and medical device production and quality management, technical support of multi-billion-dollar drug product lines, and introduction of new products onto the market.

He developed analytical technology policies, procedures, and master plans for numerous biopharmaceutical firms based on latest global regulation. He also developed analytical technology qualification programs for many pharmaceutical and biopharmaceutical firms. He has published numerous articles and white papers in pharmaceutical professional magazines. He is an author of two books on pharmaceutical scale-up and process validation. In addition, he has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, and other forums. He is also very active with PDA and ASTM participating in several task force groups authoring PDA technical reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), and 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He leads the PDA water interest group and is also a member of ASTM E55, G122).and participated in the ASTM E3106-18 Standard Guide for Science and Risk-based Approach to Cleaning Validation, and the ASTM E3219 and E3263. He holds a BS degree in mechanical/electrical engineering technology from Rochester Institute of Technology.

Justin Mason-Home, FRSC, UK

Director

HPAPI Project Services Limited

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.

Yossi Shapira, IL

Consultant and Owner

Containment Lyophilization Laboratories (CLL)

Yossi Shapira is a consultant expert in lyophilization and HPAPI processes containment and exposure solutions, as well as chemical laboratories design. He is the founder and owner of Containment Lyophilization Laboratories.

Yossi served 40 years at TEVA Pharm. Ind., where he gained substantial experience in parenterals production, freeze drying processes, HPAPI handling, and most recently he spent six years in the global engineering department on special projects and technologies.

Overall, Yossi supported investigation development and optimization scaling up of lyophilization methods and safety managing for binary organic solvents solutions, drug substances, and drug products. The lyophilization process requires laboratory studies on critical parameters. Accordingly, Yossi designed and adapted the lyophilization process, trained and taught OJT, and scaled up the tested freeze-drying processes. It was also his responsibility to review new freeze-drying processes design, and he submitted processes to regulatory bodies prior to product file submitting.

Yossi is a member of the International Society for Lyophilization Freeze Drying ISL-FD and has been a guest speaker, lecturer, trainer and chairperson at several international conferences over the years.

Andrew Walsh, US 

President 

Center for Pharmaceutical Cleaning Innovation (CPCI™) 

Andrew Walsh is president of the Center for Pharmaceutical Cleaning Innovation (CPCI™), a not-for-profit research and educational organisation and laboratory whose purpose is to support pharmaceutical, biologics, cosmetic, and medical device companies in the implementation of the science, risk, and statistics-based approaches of the ASTM E3106 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation". CPCI supports companies through its research into developing new technologies (two patents), its educational offerings (courses, workshops, and publications), and internship opportunities for students. 

Prior to joining the pharmaceutical industry, Andrew worked for 10 years at the Colgate-Palmolive and Clorox companies as an analytical chemist and microbiologist. Andrew then worked in the field of validation for over 30 years for major pharmaceutical companies; Johnson & Johnson (RWJ Pharmaceutical Research Institute, Ortho-McNeil, and Ortho-Biotech), Schering-Plough, and Hoffmann-La Roche.  

After leaving Hoffmann-La Roche in 2007,  Andy founded Clean6Sigma, LLC, to provide consulting services in cleaning process development, and cleaning validation to pharmaceutical, biotech, and medical device companies using lean and six sigma techniques. 

In 2008, Andrew became a full-time professor at Stevens Institute of Technology in their pharmaceutical manufacturing and engineering program, where he developed and taught validation and lean six sigma in pharmaceutical manufacturing courses until 2015. In 2019, Andrew joined the Temple University school of pharmacy regulatory affairs and quality assurance program to teach a graduate level course in cleaning validation. Andrew recently published a textbook,  "Cleaning Validation:  Science, Risk and Statistics-based Approaches", for use in his classes.  

Andrew is very active in developing industry consensus standards with the American Society for Standard and Materials (ASTM International) and has led the teams writing the E3106 "Standard Guide on Science-Based and Risk-Based Cleaning Process Development and Validation", the E3219 "Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)", the G121 "Standard Practice for Preparation of Contaminated Test Coupons for the Evaluation of Cleaning Agents", the G122 "Standard Test Method for Evaluating the Effectiveness of Cleaning Agents and Processes", and the E3263 "Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues". Andrew was also a co-author of the ISPE "Risk-based Manufacture of Pharmaceutical Products Guide" (Risk-MaPP) and is on the team updating the PDA Technical Report No. 29 on cleaning validation. 

Andrew has a master’s in biology (microbiology) and is a certified lean six sigma black belt and an accredited trainer. Andrew can be contacted at andywalsh@clean6sigma.com. 

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Walid El Azab is an industrial pharmacist, a qualified person, and a lean six sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. Finally, he leads audits at manufacturer sites and workshops to improve processes and inspection readiness levels. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions) and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is the secretary of the Belgium Qualified Person Association.

Thomas Altmann, DE

Technical Consultant and Validation Manager

ECOLAB

Thomas Altmann has 22 years’ experience in cleaning chemistry, cleaning process, cleaning validation, and regulatory compliance. As technical consultant and validation manager, he provides technical consultation on cleaning and sanitisation process optimisation for pharmaceutical, API, biotechnology, and personal care manufacturers in Europe, Middle East, Asia Pacific, North America, and Africa. In his role, Thomas is a subject matter expert in cleaning validation for product contact surfaces across all types of pharmaceutical and personal care production equipment.

Dr. Thomas Adam, DE

Head of QA Chemical APIs

Bayer AG

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.

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

Sunil has over 17 years of experience working in the engineering and validation fields of cGMP / FDA / EU / ISO regulated industry sectors.  

Sunil has a strong background in Cleaning Validation (CIP, COP, Manual), Process Validation, Process Design, Clean Utilities (WFI, PW, Clean Steam, Clean Air, Clean Gases), HVAC, Project Management, Sterilization and Processing Equipment Validation. Further expertise includes Process Optimization/Improvement, Regulatory Compliance and Risk Management methodologies for the pharmaceutical and biologics industry.  

Prior to joining Valgenesis, Sunil has had variety of Validation roles as consultant and corporate employee with increased responsibilities within Pharmaceutical and Biologics industry including Catalent, Eisai, Pfizer, Teva and Novartis.  

Thomas Hauser, DE

Business Development Manager EMEA

G-CON Manufacturing

Thomas Hauser works for G-CON Manufacturing in a business development assignment in the EMEA region to educate the market for offsite prefabricated and prequalified factory and clean-room solutions in a drive to bring forward the pharmaceutical facility of the future concept.

On the other hand, he supports companies in the life science segment mainly for expansion strategies, strategical facility implementation, startup support, and pharmaceutical packaging supply and technologies.

Before 2020, Thomas worked in various leading global positions in business development, strategic implementation, and sales in the pharmaceutical packaging field, namely in injectables and semi-solid and oral-solid packaging. He has more than 25 years of experience dealing with the global life science industry and its market and manufacturing requirements.

Thomas holds an international MBA from the University of Ottawa, Canada, and a BA for European business from the ESB Reutlingen and the ESC Reims.

Dr. Georg Sindelar, DE

Head of Pharma, QMS Consulting

MSG Advisors

Dr. Georg Sindelar started his pharmaceutical career in the production of monoclonal antibodies as a process engineer, covering all manufacturing/QA topics from MBR design and document control to technology transfers to cleaning validation. As a consultant, he has supported many large and small pharmaceutical companies in a wide range of GMP projects for more than 12 years, including worldwide audits and FDA inspection preparations. He is a regular speaker at national and international conferences and has published on several GMP topics.

Steve Marnach, BE

Training Manager & Cleanroom Specialist

DuPont

Steve Marnach has a master’s degree in business administration and has with DuPont since 1995. After having held various positions within the company, he is currently the EMEA training manager and critical environments marketing specialist for DuPont personal protection, the chemical protective and cleanroom garments business that Steve has been working for since 2003. In his current role, Steve provides training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade A/B and C/D cleanroom operations as well as gives technical support to health and safety specialists.

Dr. Friederike Hermann, CH

Head of Occupational Hygiene

Lonza

Dr. Friederike Hermann is Head of Occupational Hygiene at Lonza Visp. She ob­tained her doctorate in the field of Analytical Chemistry with an emphasis on Element Speciation. In 2001, Dr. Hermann started as an Analytical Chemist in the Environmental Department and eventually transitioned into the field of Occupational Hygiene. She was significantly involved in the setup of high potent compound production at Lonza. She completed her Master of Advanced Stud­ies (MAS) degree on Work and Health at the ETH Zürich and the University of Lausanne. Dr. Hermann is a certified hygienist through the Swiss Society of Occupational Hygiene. She is a member of the steering committee of COP Con­tainment ISPE Affiliate DACH. She is also a member of the MAK Commission Switzerland and actively participates in a network of Occupational Hygienists, Physicians and Toxicologists, which form the Basel Chemical Industry (BCI). She is also a member of the Health Commission for the Lonza Visp site, which has over 3,000 employees. She lives in Wallis, Switzerland, where she enjoys run­ning, cycling and hiking.

Dr. Martin Kohan, UK

Managing Toxicologist

SafeBridge Europe

Martin Kohan is a managing toxicologist for SafeBridge Regulatory and Life Sciences Group. He has a BSc and MSc in biochemistry from La Plata National University, Argentina, as well as an MSc in pharmacology and PhD in medical sciences from the Hebrew University of Jerusalem, Israel. Martin has over 11 years of industry experience in the field of toxicology conducting and managing over 1,000 hazard and risk assessments, including calculation of exposure limits and/or determination of exposure control bands for drug substances and isolated intermediates and quality deviations (impurities and extractables and leachables) for Teva (2010-18) and AstraZeneca (2018-22). He's a Diplomate of the American Board of Toxicology (DABT), a European Registered Toxicologist (ERT), and a member of the UK Register of Toxicologists and the British Toxicology Society.

Susan B. Cleary, CA

Director of Product Development

Novatek International

Susan B. 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.

Thomas Weingartner, DE

Managing Director

Lugaia Deutschland GmbH

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.

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Igor Gorsky, US

Principal Process Validation Consultant

ValSource Inc.

Justin Mason-Home, FRSC, UK

Director

HPAPI Project Services Limited

Yossi Shapira, IL

Consultant and Owner

Containment Lyophilization Laboratories (CLL)

Andrew Walsh, US 

President 

Center for Pharmaceutical Cleaning Innovation (CPCI™) 

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Thomas Altmann, DE

Technical Consultant and Validation Manager

ECOLAB

Dr. Thomas Adam, DE

Head of QA Chemical APIs

Bayer AG

Sunil Patel, US

Director – Product Management

ValGenesis, Inc. 

Thomas Hauser, DE

Business Development Manager EMEA

G-CON Manufacturing

Dr. Georg Sindelar, DE

Head of Pharma, QMS Consulting

MSG Advisors

Steve Marnach, BE

Training Manager & Cleanroom Specialist

DuPont

Dr. Friederike Hermann, CH

Head of Occupational Hygiene

Lonza

Dr. Martin Kohan, UK

Managing Toxicologist

SafeBridge Europe

Susan B. Cleary, CA

Director of Product Development

Novatek International

Thomas Weingartner, DE

Managing Director

Lugaia Deutschland GmbH

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What our
participants
are saying

I want to extend my gratitude and appreciation for providing such a quality platform for this very important part of our industry!

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Robert B. Wood IV

Scientist II at FUJIFILM Diosynth Biotechnologies

"We had very interesting discussions with the different participants about our industry and the latest trends. Thanks to Vonlanthen for organizing another great HPAPI."

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Paolo Bento

Regional Sales Manager at ILC Dover

"Big thank you to all the speakers at the #5VLHPAPI Summit in Rome. Fantastic insights from a diverse group of industry experts and great presentations from all involved."

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Jessica Pearson

Occupational Hygiene Consultant at Armstrong Environmental Limited