Life Scinces Series: 
Cleaning Validation for Pharma

Online Conference

07-08 December, 2021 

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About

Cleaning Validation for Pharma 2021
Online Conference

Future Bridge is thrilled to announce the Cleaning Validation for Pharma Online Conference.

Cleaning Validation is a crucial component of an effective GMP Compliance program at any regulated drug manufacturing facility. During the last years, it has been one of the most evolving and debated topics in the pharma industry.

This event offers you a unique possibility to explore the current status and efficient implementation techniques of Cleaning Validation Guidelines.

Through the practical presentations and case studies from industry experts, you will examine the best practices of cleaning validation challenges relating to quality aspects, cleanroom technologies, and environmental monitoring considerations.

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Program Highlights:
  • Emerging regulations and new compliance standards

  • Cleaning process development,

  • Contamination control strategy,

  • Grouping products and equipment for cleaning validation,

  • Risk-based cleaning validation monitoring,

  • Future of cleanroom design

Who Should Attend:

​​Vice-Presidents, Directors, Managers, and Heads responsible for:​

  • Cleaning Validation

  • Cleanroom Technology

  • Aseptic Processing

  • Sterile Technology

  • Microbiology

  • Microbe Monitoring and Control

  • Technical Services

  • Contamination control

  • Manufacturing Science & Technology 

  • Process Monitoring and Control

  • Environmental Monitoring

  • Toxicology

  • QA/QC

  • Risk Management

  • Regulatory Affairs
     

Special Thanks to Our Sponsors
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Gold Sponsor 

Bronze Sponsor 

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Bronze Sponsor 

Business Development Sponsor 

the Speakers

   USA

Mihir Vashi

Leader & Change Agent for Risk-Based Validation

Alcon

Mr. Vashi is a proven leader & a change agent with over sixteen (16) years of experience in validation, risk management, product transfer & technical project management for the pharmaceutical (injectable, OTC & solid dosage) and medical device industries.

He is a value-focused professional with experience in implementing streamlined processes/procedures to facilitate robust Quality Management Systems ensuring operational efficiency, user/patient safety while meeting regulatory requirements.
 

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abstract

Andreas Schreiner

Director of Validation, 
Manufacturing Science & Technology

Novartis

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Andreas Schreiner graduated from the University Erlangen, Germany in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London he joint 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.

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   Switzerland

   USA

Fred Ohsiek

Senior Cleaning Validation Specialist 

Novo Nordisk

Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from the University of South Florida. His professional work experience includes seven years of R&D performing enzymatic digestion, ultrafiltration, and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered a subject matter expert in cleaning validation in most positions held.

His cleaning validation experience includes developing, validating, and monitoring cleaning processes for equipment used to
manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large
molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved API and finish product manufacturing
start-up, remediation, legacy process justification, and increasing manufacturing capability. He has authored documents
and executed in every aspect of the cleaning validation process. 
He has conducted risk assessments for initiation of cleaning validation program/scope, determining cleaning monitoring frequency, and dated cleaning validation packages. 
He was one of the authors of the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and lead the chapter on cleaning validation acceptance criteria.

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The sustainable transport solution of the future – Autonomous & Electrified

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Bronze Sponsor

Sebastian Scheler

Chief Methodologist

INNERSPACE GmbH

abstract

Sebastian Scheler is co-founder and chief methodologist of Innerspace, a provider of virtual reality simulators specializing in pharmaceutical manufacturing. Scheler is a psychologist by profession and has many years of experience in psychological training and methodology development. At Innerspace, Scheler is responsible for simulator methodology and business relations with international clients in the pharmaceutical industry. He is also a speaker at numerous professional events and an active member of the ISPE Pharma 4.0 working group

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   Austria

   Germany

Dr. Carl-Helmut Coulon

Head of Future Manufacturing Concepts

INVITE GmbH

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Dr. Carl-Helmut Coulon
Head of Future Manufacturing Concepts

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Dr. Carl-Helmut Coulon
Head of Future Manufacturing Concepts

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Business Development Sponsor

Dipl. Ing. Matthias Buttazoni

CTO

Ortner Reinraumtechnik GmbH

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Dipl. Ing. Matthias Buttazoni
CTO
Ortner Reinraumtechnik GmbH

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   Austria

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