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RESCHEDULED: Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables Seminar Philadelphia 2020

Event

September 22, 2020 - September 24, 2020

Price

All 3 Days: $899.00 per person.
Days 1 & 2: $699 per person.
Day 3: $399 per person.

Location

Philadelphia, PA

Contact Information

Contact Mike Pizzi at mpizzi@nelsonlabs.com or +1 (801) 290-7524 for more information


RESCHEDULED

As a global leader in Safeguarding Global Health®, Nelson Labs’ top priority remains the health and well being of our customers, their patients, and our employees worldwide.  We have been closely monitoring developments concerning the Novel Coronavirus (COVID-19) and have decided to reschedule this seminar to SEPTEMBER 22-24, 2020

If you are currently scheduled to attend this seminar, you will be contacted regarding options for attending this or other scheduled Nelson Labs’ seminars.


Learn how to achieve more successful testing outcomes and enhance your sterility assurance knowledge by attending this exclusive 3-day seminar: Pharmaceutical Sterility Assurance, Contamination Control, and Extractables & Leachables: Trends, Test Methods, and Current Thinking in Philadelphia.

The aim of this three-day seminar is to provide pharmaceutical companies the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes. Attendees will also gain a basic understanding of the principals of Terminal Sterilization versus Aseptic Processing as well as explore the use of various sterilization technologies suitable for drug products including Steam, Radiation (Gamma and E-Beam), Ethylene Oxide and Nitrogen Dioxide.

Seminar participants will enjoy classes taught by Nelson Labs’ and Sterigenics’ Expert Advisors.

Nelson Labs, a Sotera Health company, is the industry-leading provider of global lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues

Sterigenics is a global leader in comprehensive sterilization solutions and advisory services. We are over 1600 engineers, scientists and safety specialists with deep expertise across Gamma, EtO, E-Beam and X-Ray sterilization.  Our operations span 47 facilities in 13 countries to ensure we are the “point of safe” for our customers.

COURSE HIGHLIGHTS INCLUDE:

Download The Agenda Here


Tuesday, Sept 22, 2020

  • Introduction to Nelson Labs and Sterigenics– Mike Pizzi
  • Comparison Between Aseptic Processing and Terminal Sterilization- Annick Gillet, Sterigenics
  • Terminal Sterilization Concepts – Martell Winters, Nelson Labs
  • EO Sterilization: Concepts & Applications on Pharmaceutical Products- Annick Gillet, Sterigenics
  • Radiation Sterilization and Concepts– Bart Croonenborghs, Sterigenics
  • Concepts from ISO 19930:2017 and AAMI ST 67- Martell Winters, Nelson Labs
  • NO2 Sterilization- David Opie, Noxilizer
  • What Does a Sterility Assurance Program Look Like?- Martell Winters
  • Cleaning & Disinfection Efficacy Validations of Sanitizing Agents – Josef Mastej, Nelson Labs

*Times and topics subject to change


Wednesday, Sept 23, 2020

  • Endotoxin Control including inhibition and enhancement- Dan Lovero, Nelson Labs Fairfield
  • Particulate Testing for Pharmaceutical Products- Tonya Morris, Nelson Labs
  • Filtration Sterilization Validation for an Aseptic Process- Tonya Morris, Nelson Labs
  • Terminal sterilization using moist heat – Jason Pope, Nelson Labs
  • ICH Stability Testing and Method Development- Shiri Hechter, Nelson Labs Fairfield
  • Container Closure Integrity Testing – Mass Extraction – Jen Gygi

*Times and topics subject to change


Thursday, Sept 24, 2020

  • Introduction to Extractables and Leachables – Anja Cerstiaens, Nelson Labs Europe
    • Definitions
    • General concepts
    • Regulatory landscape
  • Mechanism of Leaching – Dries Cardoen, Nelson Labs Europe
    • Polymers 101
    • Glass 101
    • Mechanism of Leaching
  • Extractables Studies : Do’s and Dont’s – Dries Cardoen, Nelson Labs Europe
    • Tailor-made study designs
    • Common pitfalls
  • How to Bridge Between Extractables and Leachables Studies – Anja Cerstiaens, Nelson Labs Europe
    • The threshold approach
    • Case study
  • Leachables Studies : Do’s and Dont’s – Dries Cardoen, Nelson Labs Europe
    • Tailor-made study designs
    • Common pitfalls
  • Practical Approaches in E&L – Anja Cerstiaens, Nelson Labs Europe
    • Analytical techniques
  • Case Studies – Anja Cerstiaens, Nelson Labs Europe
    • The impact of sterilization on the E&L profile
  • Q&A – open discussion

*Times and topics subject to change


Event Registration:

Registration for all 3 days is $899 per person (BEST DEAL)

Registration for Days 1 & 2 is $699 per person

Registration for Day 3 is $399 per person

Registration deadline is September 9, 2020

 

Lunch and refreshments will be served daily and are included in the seminar package. Please note, however, that the registration fee does not include hotel accommodations.

Hotel Accommodations:

Guests planning to stay on location may coordinate their hotel reservation online. The negotiated rate is $169.00 per night. This offer is good until August 30, 2020 or until sold out

Group Event Registration:

Groups of three or more may contact Mike Pizzi at mpizzi@nelsonlabs.com or +1 (801) 290-7524 for discounted pricing information.

Seminar Cancellation Policy

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