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3rd Cleaning Validation Live Event

  • 3rd June 2021
  • Zoom flag Zoom
  • ONLINE

Starting at 12:20 pm CET, we are going to be streaming exclusively for our attendees, 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.

 

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About the 3rd Cleaning Validation Live Event

We are bringing you live presentations on how to maintain and  manage the cleaning program and meet regulatory requirements.  Led by subject-matter experts, who will cover exciting topics that  are gaining increased attention in the industry, followed up with an  interactive discussion with an emphasis on understanding the best  practices for an effective and efficient cleaning validation program.

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
  • Pharmaceuticals
  • Biotechnology
  • Mechanical Engineering
  • CMO
  • 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

  • The impact of PH on solubility
  • Setting up trials to categorize (Ph. Eur) Apis Solubility at different PH
  • Take command of your cleaning validation process with Uncle
  • Cleaning validation maintenance program
  • Develop an environmental monitoring (EM) approach for non-sterile environment 
  • Critical cleaning
  • Establishing risk-based EM program for non-sterile environment

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.

Jernej Rabzelj, SL

Technical Steward Lek Solids

Novartis

Jernej has a Master's degree in pharmaceutics. He has been in Novartis for eight years in MS&T (Manufacturing science and technology) department and has expertise in Product Validation, Packaging Validation, and Cleaning Validation.

Fred Ohsiek, US

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.

Dr. Carsten B. Senholt, DK

Chief Technical Officer / Principal Toxicologist, DVM, M.Sc. Applied Tox, ERT

SAXOCON

20+ years of expertise as a toxicologist specialized in risk assessment of pharmaceutical excipients, impurities, and leachables from materials of construction used in medical devices and drug/device combination products. Member of the International Standardisation Organisation Technical Committee 194 working group for several biocompatibility standards of medical devices (ISO 10993 series). Assessment of pharmaceutical excipients, impurities, and leachables from materials of construction used in delivery devices and manufacturing of drug products. Driver of innovation in strategies and development of state-of-art practices for health risk assessment of polymer materials.

Mihir Vashi, US

Validation Lead

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.

Jeff Phillips, US

Senior Director, Science and Marketing

Alconox Inc

Senior Director, Science & Marketing 20+ yrs pharmaceutical, cGMP, analysis, cleaning, process, and cleaning validation, sterility, and risk assessment. Jeff worked with companies such as Wyeth, Pfizer, Roche, Watson, Stryker, and many others.

Riffard Jean-Gilles, US

Senior Director of Field Applications Science

Unchained Labs

Riffard Jean-Gilles is the Senior Director of Field Applications Science at Unchained Labs. He has served in various leadership and technical roles at Unchained Labs. Prior to Unchained Labs, he worked as an applications scientist at Malvern Instruments, earning several company awards. He worked in R&D at GE’s Global Research center, publishing several patents and publications on optical materials development and worked on multiplex antibody platform developments. Additionally, he’s published and holds patents in protein functionalization and biomaterials development for artificial tissue engineering. He holds graduate degrees in Chemistry and biotechnology management from Villanova University and Harvard University.

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

Jernej Rabzelj, SL

Technical Steward Lek Solids

Novartis

Fred Ohsiek, US

Senior Cleaning Validation Specialist

Novo Nordisk

Dr. Carsten B. Senholt, DK

Chief Technical Officer / Principal Toxicologist, DVM, M.Sc. Applied Tox, ERT

SAXOCON

Mihir Vashi, US

Validation Lead

Alcon

Jeff Phillips, US

Senior Director, Science and Marketing

Alconox Inc

Riffard Jean-Gilles, US

Senior Director of Field Applications Science

Unchained Labs

BROCHURE  

Request the 3rd Cleaning Validation Live Event brochure and find out the latest topics and ideas that will be shared.

Request

Please fill in your e-mail address below and we will process your request in a moment.

What our
participants
are saying

I found the Online Cleaning Validation and Environmental Monitoring very informative, great length, great speakers. Just next time, schedule or plan for the 4 hours vs. 3 hours.

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Attendee

Interesting webinar with reasonable price including questions and answers part.Thank you for a great event! Looking forward to future events as an attendee or perhaps a presenter.

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Attendee

I would rate this event as excellent. I really liked your webinar and hope that you will keep contacting me with more interesting and helpful topics as they were on this webinar. Thank you.

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Attendee