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Pharma

4th Cleaning Validation Live Event

  • 17th February 2022
  • Zoom flag Zoom ONLINE

This year's most insightful and interesting presentations will be coming to you wherever you are at the 4th Cleaning Validation Live Event on February 17, 2022. You'll hear from market leaders, industry regulators, and manufacturers, who will share the critical conditions and case studies for an effective and most efficient cleaning validation program. Including:

  • Cleanability trials – laboratory bench scale studies
  • Defining the most appropriate program validation or verification
  • Challenges of health-based exposure limits (HBELs)

Also, the most important part of our meeting will be the opportunity to ask questions to our panel of some of the most renowned experts in the field. These and other opportunities are waiting for you at our 4th Cleaning Validation Live Event!

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About the 4th Cleaning Validation Live Event

We are bringing you live presentations on how to maintain and manage your cleaning program and meet regulatory requirements.

Leading professionals will share their experiences and highlight the most interesting topics that are gaining increasing attention in the industry, followed by an interactive discussion on understanding best practices for an effective and efficient cleaning validation program.

Who Should Attend

Executives, Directors, Heads, Leaders, Managers, Specialists, Engineers Professionals in Pharmaceuticals, 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
  • Manufacturing Science & Technology
  • Regulatory Affairs
  • CMC
  • Research & Development
  • Risk Management
  • Pharmaceuticals
  • Biotechnology
  • Documentation & Analysis
  • Plant Management
  • Process Monitoring & Control
  • Analytical Development Laboratories
  • Internal & External Audit
  • Mechanical Engineering
  • Training Departments
  • Engineering
  • Validation
  • Production
  • QA/QC
  • CMO
  • Technology Transfer
  • Other

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Cleanability trials – laboratory bench scale studies
  • Regulatory expectations
  • Defining the most appropriate program validation or verification
  • Challenges of health-based exposure limits (HBELs)
  • Levels of documentation for cleaning applications

Igor Gorsky, US

Principal, Process Validation Consultant

ValSource Inc.

Dr. Ester Lovsin, CH

Head Product Stewardship and Health

Takeda

Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda. Previously she has held corporate positions at Lonza and Novartis. Her responsibilities include regulatory and SDS related topics, scientific development and cross-organizational implementation of health based exposure limits (HBEL), compiling global policy product stewardship related process in sup­port of manufacturing in Takeda globally, as well as global implementation of industrial hygiene. She received her PhD in veterinary sciences from the University of Ljubljana, Slovenia, and a second master's degree in toxicology and risk assess­ment from Medical University in Vienna. Dr. Lovsin Barle is the author/co-author of over 70 publications including peer-reviewed articles and book chapters. She is a member of several pharma industries and toxicological associations and boards and has served as the president of the Slovenian Society of toxicology. She lec­tures at several universities. Privately she is a mother of two and is enthusias­tic about balanced and healthy lifestyle which includes components of triathlon, mountain hiking and good food.

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.

Andreas Schreiner, CH

Global Validation Network Leader/Validation Lead

Novartis

Andreas Schreiner graduated from the University of Erlangen, Germany, in 1996 in chemical engineering. After a PhD and a scholarship at the University College London, he joined Roche Vitamins as head of solids processing. Since 2006, Andreas has worked for Novartis in various departments with increasing responsibilities from project leader to global technology platform leader; currently, he is heading the validation activities for pharmaceutical production of solid dosage forms. Andreas is an appointed board member at various scientific organisations, including the Executive Board of European Federation of Chemical Engineers (EFCE), Swiss Society for Process Engineers (SGVC), Industrial Society for Pharmaceutical Engineering (ISPE), and Swiss Laboratory of Material Science and Technology (EMPA). Since 2013, he has worked for the manufacturing science and technology department as validation head for solid dosage forms.

Igor Gorsky, US

Principal, Process Validation Consultant

ValSource Inc.

Dr. Ester Lovsin, CH

Head Product Stewardship and Health

Takeda

Walid El Azab, BE

Technical Service Manager

STERIS Corporation

Thomas Altmann, DE

Technical Consultant and Validation Manager

ECOLAB

Andreas Schreiner, CH

Global Validation Network Leader/Validation Lead

Novartis

BROCHURE

Request the 4th Cleaning Validation Live Event brochure and find out the latest topics and ideas that will be shared during the event.

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