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Pharma

Cleaning Validation and Environmental Monitoring

  • 5th June 2020
  • Webex flag Webex
  • ONLINE

We are introducing a topic with an increasing amount of attention from industry regulators and manufacturers with an emphasis on understanding the best practices for an effective and efficient cleaning validation program.

To BUY the RECORDING of the Live Event, contact us via mail gabriela.vladimirova@vonlanthen-conferences.com

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About

Be a part of the live event Cleaning Validation and Environmental Monitoring and exchange ideas through audio/video conferencing and live chat during each presentation in real-time!

Starting at 1:00 pm CET, we are going to be streaming exclusively for our clients, introducing a topic with an increasing amount of attention from industry regulators and manufacturers with an emphasis on understanding the best practices for an effective and most efficient cleaning validation program. 

We gathered four industry experts, who will present you with informative live presentations on how to maintain and manage cleaning program and meet regulatory requirements.

The practical part of our live session will cover a Novartis case study presenting cleaning validation as one driver to prevent cross-contamination.

Who should attend

Executives, Directors, Heads, Leaders, Managers, Specialists, Engineers and Fellows specializing in:

  • Biotechnology
  • Engineering
  • Cleaning Validation
  • Aseptic Processing
  • Chemistry
  • CMC
  • Manufacturing Science & Technology
  • Process Monitoring and Control
  • QA/QC
  • R&D
  • Risk Management
  • Audit
  • Regulatory Affairs

What industry

  • Pharmaceuticals
  • Biotechnology
  • Medical Devices
    Mechanical Engineering
  • Industrial Automation

Key Practical Learning Points

  • Cleaning Validation as One Driver to Prevent Cross-Contamination
  • Cleaning Validation: Surface Cleanliness Monitoring Practices
  • Microbiological Aspects of Cleaning Validation  
  • Presentation Cleanroom Classification vs. Online Monitoring

Andreas Schreiner, CH

Director of Validation, Manufacturing Science & Technology Novartis

Novartis 

Andreas Schreiner graduated from the University of Erlangen, Germany, in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London, he joined Roche Vitamins as Head of Solids Processing. Since 2006 Andreas Schreiner 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 Schreiner is appointed board member at various scientific organisations (Executive Board of European Federation of Chemical Engineers (EFCE), Swiss Society for Process Engineers (SGVC), Industrial Society for Pharmaceutical Engineering (ISPE), Swiss Laboratory of Material Science and Technology (EMPA)). Since 2013 he works for the Manufacturing Science & Technology Department as Validation Head for Solid Dosage Forms. 

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

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 level. 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 secretary of the Belgium Qualified Person Association.

Dr. Tim Sandle, UK

Head of Microbiology and Sterility Assurance

Bio Products Laboratory Limited

Dr. Tim Sandle has over twenty-five years of experience in microbiological research and biopharmaceutical processing. Dr. Sandle is a member of several editorials boards, and he has written over six-hundred book chapters, peer-reviewed papers, and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK and is a visiting tutor at both the University of Manchester and UCL. 

Hasim Solmaz, TR

General Manager, EMEA

Lighthouse Worldwide Solutions

Hasim Solmaz is the General Manager of Lighthouse Worldwide Solutions EMEA Operations. Hasim's focus is on cleanroom design and management concepts, environmental monitoring systems, pharmaceutical manufacturing, and regulatory concerns. Hasim is a founding chair of Cleanroom Technologies Society of Turkey, head of delegates in ISO TC209 "Cleanrooms and associated controlled environments" and expert in ISO TC209 "Cleanrooms and associated controlled environments" Working Group 3 "Cleanroom Test Methods." Recently appointed as honorary chair of ICCCS, The International Confederation of Contamination Control Societies, which is an international community for national society on cleanrooms and contamination control. Hasim is an active member of the International Society for Pharmaceutical Engineering (ISPE), Institute of Environmental Sciences and Technology (IEST) and Parenteral Drug Association (PDA). He holds a Bachelor of Science degree with high honour's in Atmospheric Science and Meteorological Engineering from Istanbul Technical University.

Valeria Uberti Foppa, IT

Senior Business Development Manager

Copan Italia Spa

Valeria Uberti Foppa – graduated in languages at University. With 24 years of experience in promoting and selling collection and transport medical devices and IVDs at COPAN, Valeria supports the activities

of the B2C distribution network as Export area Manager, Customer care Manager and lately Senior Business and Development Manager, in the clinical and environmental field.

Area of action: EMEA territories

Andreas Schreiner, CH

Director of Validation, Manufacturing Science & Technology Novartis

Novartis 

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

Dr. Tim Sandle, UK

Head of Microbiology and Sterility Assurance

Bio Products Laboratory Limited

Hasim Solmaz, TR

General Manager, EMEA

Lighthouse Worldwide Solutions

Valeria Uberti Foppa, IT

Senior Business Development Manager

Copan Italia Spa

What our
participants
are saying

“I (and many others from the conference) think this is the best European conference on Aseptic Filling technology. Very interesting conference.”

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Enrico Zanetti

Swissfillon AG

“It was a pleasure to give a speech at the 3rd Annual Aseptic Processing Summit in Vienna! Great exchange of expertise and very wide networking across Pharma & Biopharma Companies. Thanks to you for the invitation! “

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Nicola Rutigliani

Merck

“Thanks' to the organiser and the rest of the Vonlanthen team for a well-organized summit in Vienna - and an extended thank you to all speakers and participants for all the good discussions and networking during the two days we had together!“

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Henrietta Vinnerås

Fresenius Kabi

Great speakers & exemplary knowledge sharing across the industry!”

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Wolfgang Oitzinger

Takeda