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Cleaning Validation
for Pharma

07-08 December, 2021  |   Online Conference

#FBcleaningvalidation

 
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:
  • 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
     

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Gold Sponsor 

Digitized validation for the fastest time to market

ValGenesis, Inc. is the creator of the industry’s leading Validation Lifecycle Management System (VLMS). This innovative platform handles the entire corporate validation lifecycle and is used by 30 of the top 50 global life science companies.


ValGenesis was the first entirely paperless electronic solution for managing validation and remains the most complete solution on the market, covering computer system validation, computer software assurance, electronic logbook, reliability traceability matrix, process, method, and more. Customers specifically cite significant increases in teamwork and process efficiency, reduction in errors and strengthened data integrity, standardization of procedures, and 50% cost reductions in validation programs.

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Special Thanks to Our Sponsors

Bronze Sponsor 

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Bronze Sponsor 

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Business Development Sponsor 

The Speakers
 

   USA

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Fred Ohsiek

Senior Cleaning Validation Specialist 

Novo Nordisk

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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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Richard Denk

Senior Consultant Aseptic Processing & Containment

SKAN AG

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abstract

Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment.

 

Richard is member of the PDA Isolator Expert Group, ISPE Sterile Product Processing Group, Chair of the ISPE Containment DACH, the ISPE SIG Robotic and Co-Chair ISPE SIG Bio on Innovations and Technology.

 

Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group

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   Switzerland

   USA

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Mihir Vashi

Leader & Change Agent for Risk-Based Validation

Alcon

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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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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

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Beth Kroeger-Fahnestock

Technical Service Senior Manager

STERIS Corporation
Life Sciences

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Beth Kroeger is a Technical Services Senior Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to contamination investigations, cleaning and process validation and cleanroom environmental control, frequently speaking on these topics for several industry and educational organizations. Beth has extensive industry experience in Biopharmaceutical Manufacturing, Validation, Technical Transfer, R&D, Compliance, and Quality from her various positions she has held at Sigma Diagnostics (Millipore Sigma), Wyeth, Centocor (Janssen) Biologics, and Biotest Pharmaceuticals. Her areas of expertise include large scale fermentation systems, both continuous perfusion and fed batch, and downstream operations including large scale purification and column pack, viral removal, UF and final fill. She earned a B.S. in Biochemistry from the University of Missouri, St. Louis and is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program for the Spring semester 2020. She served on the ISPE task force to draft Cleaning Validation Guidelines for Biopharmaceutical Operations and is the Vice-Chair of the ASTM D37 committee

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Walid El Azab

Technical Service Senior Manager 

STERIS Corporation 

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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 sterilization 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.
 

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   Belgium

   Denmark

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Dr. Carsten B. Senholt

CTO & Partner

Saxocon

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Dr. Carsten B. Senholt, DK
CTO & Partner
Saxocon 

 

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Permitted Daily Exposure for cleaning risk management

  • Requirements for establishing health based limits to support maximum allowable carry-over

  • Methods and principles for establishing PDE for cleanings agents and active ingredients

  • Special consideration in biopharmaceuticals

  • Case studies

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Dr. David W. Vincent

CEO

VTI Life Sciences

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Developing a cleaning validation program meeting regulatory expectations

  • Regulatory observations ( 483s, warning letters) associated with cleaning programs

  • Current regulatory agencies Inspection trends related to cleaning validation.

  • Regulatory and quality pit falls related to cleaning validation programs

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Dr. David W. Vincent, US
CEO
VTI Life Sciences

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   USA

   USA

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Brian G. Hubka,

CEO

Contamination Prevention
Technologies, Inc.

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Brian G. Hubka, US
CEO
Contamination Prevention Technologies, Inc.

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Brian G. Hubka, US
CEO
Contamination Prevention Technologies, Inc.

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Gold Sponsor

Sunil Patel

Director of Product Management and COE

ValGenesis

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Topic Digitization of Cleaning Validation Life-cycle

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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 OptimizationImprovement, 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. 

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   USA

   Austria

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Sebastian Scheler

Chief Methodologist

INNERSPACE GmbH

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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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

   Germany

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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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Cleaning Validation
for Pharma

07-08 December, 2021  |   Online Conference

#FBcleaningvalidation

Alex Kim

Event Manager

phone: +44 203 9363 449
email:   alex.kim@future-bridge.eu