2021 ISPE Best of Pharma Series: Aseptic

Best & Brightest Aseptic Content from the 2021 Conferences

33 Presentations Featuring 18+ Hours of Content

No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2021, hand-selected the absolute best and brightest aseptic presentations and packaged them into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.

ISPE Best of Pharma Series: Aseptic

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

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Sneak Peek of What to Expect

Watch this short clip from James L Drinkwater, P.E presenting Annex 1 Barrier Technologies, Classification-Qualification (PHSS) for a glimpse of the kind of content you’ll engage within the ISPE Best of Pharma Series: Aseptic.


Presentations in this Package

Partner Solutions

Risk Reduction, Reliability, and Sustainability: The Drivers for Modernization of Sterile Manufacturing

Speaker: 

  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
Duration: 20 min

Partner Solutions

Contamination and Cross Contamination Control for Bio Safety

Speaker: 

  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Duration: 58 min

Partner Solutions

Vaccines for the World - Insights into Design and Execution of a BSL2 Fill-Finish Facility

Speakers: 

  • Matthias Angelmaier, Global Product Manager, Isolator Technology, Syntegon Technology GmbH
  • Rutger Vandiest, Senior Director - Global Head of Sales, CDMO, Bavarian Nordic
  • Mark Miller, Director of Projects, EMEA-UK, IPS
Duration: 41 min

Partner Solutions

BIOSAFETY Project

Speakers: 

  • Florian Burkart, Student, ISPE Student Chapter of Albstadt Sigmaringen
  • Christoph Bierer, Student, Chair of the ISPE Student Chapter Technical University Munich
Duration: 13 min

Partner Solutions

Facility Considerations for Next-Generation Sterile Product Manufacturing

Speakers: 

  • Keith W. Weseli, CPIP, Director of Operations, Midwest Region, CAI 
  • Peter A. Walters, Director, Advanced Therapies, CRB 
  • Matthew Hewitt, Head of Clinical Development; Head of R&D, Lonza
  • Jeffrey Kent, Project Engineer, A/E Projects,, DPS Group
Duration: 50 min

Partner Solutions

Are You Protecting Your Employees During HPAPI Manufacturing?

Speaker: 

  • Tom Evans, Director; Environmental Health and Safety, Abzena
Duration: 15 min

Partner Solutions

Aseptic Meets High-Potent – Setting the Stage for Next Level HPAPI Processing

Speakers: 

  • Matthias Angelmaier, Global Product Manager, Isolator Technology, Syntegon Technology GmbH
  • Christoph Knoop, PhD., Principal Research Scientist, AbbVie Deutschland GmbH & Co. KG
Duration: 15 min

Partner Solutions

Revision of EU Gmps Annex 1: What Impacts Can We Expect as an Industry?

Speakers: 

  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & CO
  • Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
  • James L. Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, F. Ziel GmbH
Duration: 60 min

Partner Solutions

Update on Annex 1 Eudralex Vol. 4 Revision

Speakers: 

  • Jean Francois Duliere, Pharmaceutical Senior Expert, Chair ISPE France Affiliate, Consultant, Chair ISPE France Affiliate
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
Duration: 30 min

Partner Solutions

Annex 1 Barrier Technologies, Classification-Qualification (PHSS)

Speaker: 

  • James L Drinkwater, P.E., Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
Duration: 13 min

Partner Solutions

H2O2: Not the Same Old Topic

Speakers: 

  • Christa B. Myers, Senior Associate, Aseptic & Sterile Market Director, CRB 
  • Markus Lesch, PhD, Head of Microbiological Validation, Vetter Pharma-Fertigung GmbH & Co KG
  • Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Duration: 60 min

Partner Solutions

Cycle Development & Validation of Automated AHP Decontamination Processes for Cleanrooms

Speaker: 

  • Marcus Lesch, PhD, Vetter Pharma-Fertigung GmbH & Co. KG
Duration: 12 min

Partner Solutions

How Can Hydrogen Peroxide Affect Your Aseptic Process?

Speaker: 

  • Andreas Demmler, PhD, Team Leader Development Biodecontamination, METALL+PLASTIC GmbH / OPTIMA Pharma
Duration: 18 min

Partner Solutions

Modular Robotic Fill/Finish Lines

Speakers: 

  • Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH 
  • Georg Frinke, Senior Engineering Manager, Ferring GmbH
  • Thomas Thurn, Director Drug Product Clinical Supply Chain, Janssen Pharmaceuticals
  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
Duration: 60 min

Partner Solutions

EM for Fully Automated Aseptic Operations

Speakers: 

  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
  • Thomas Thurn, Director Drug Product Clinical Supply Chain, Janssen Pharmaceuticals
Duration: 20 min

Partner Solutions

Single Use Technologies – Are They Sustainable?

Speakers: 

  • Dina Manfredi, Director of Sales and Business Development, GMP Systems Inc 
  • William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
  • Magali Barbaroux, Corporate Research Fellow, Sartorius Stedim FMT SAS 
  • Joe Neroni, Director, Project Farma
  • Scott Bertch, Exec. Director, Clinical Site Head, Tenaya Therapeutics
Duration: 60 min

Partner Solutions

Utilizing Modular Cleanrooms and Single-Use Technologies

Speaker: 

  • William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
Duration: 15 min

Partner Solutions

Replacing Silicone Oil Emulsion in Parenteral Filling

Speaker: 

  • Stefan Schreyer, Alliance Manager, Vetter Pharma International GmbH
Duration: 15 min

Partner Solutions

Devices and Decontamination—Overcoming Challenges

Speakers: 

  • Keith W. Weseli, CPIP, Director of Operations, Midwest Region, CAI
  • Massimiliano Cesarini, MSEng, Sales Director, Romaco SRL
  • Ken Nagai, MBA, Director, New Business Development, Airex Co., Ltd
Duration: 55 min

Partner Solutions

Decontamination 5.0: From ATMPs and Aging Facilities to our “COVIDed” Office Room

Speaker: 

  • Ken Nagai, MBA, Director, New Business Development, Airex Co., Ltd
Duration: 15 min

Partner Solutions

Combination Products Aseptically Filled – Challenges

Speaker: 

  • Massimiliano Cesarini, MSEng, Sales Director, Romaco SRL
Duration: 15 min

Partner Solutions

Update PIC/S Annex 2A Draft for ATMPs Revision

Speakers: 

  • Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
  • Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
Duration: 15 min

Partner Solutions

Interactive Regulatory Panel

Speakers: 

  • David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ
  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
  • Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
  • Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
  • Richard Friedman, CDER/FDA
  • Thomas J. Arista, Consumer Safety Officer, FDA/ORA
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
Duration: 106 min

Partner Solutions

Case Study 4: Aseptic Processing Controls

Speakers: 

  • José Meléndez, Consumer Safety Officer, FDA/ORA
  • Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, CDER/FDA
Duration: 75 min

Partner Solutions

Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks

Speakers: 

  • Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
  • Volker Huppert, Chief Development Officer, Glycostem Therapeutics
  • René Thürmer, Quality Assessor, BfArm
  • Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
  • Giuseppina Sandri, Associate Professor, University of Pavia
  • Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TG
Duration: 20 min

Partner Solutions

Next Steps: New Industry Standard for fill/finish Technology

Speakers: 

  • Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
  • Ute Schleyer, PhD, Project Manager Site Development, Vetter Pharma-Fertigung GmbH & Co
Duration: 30 min

Partner Solutions

Vaccines for the World - Insights into a BSL2 fill-finish Facility

Speakers: 

  • Laura Moody, PhD, Product Manager, Syntegon Pharma Technology
  • Thomas O’Sullivan, Director of Aseptic Technology, IPS
Duration: 40 min

Partner Solutions

Is Your Facility on Borrowed Time? Part 1

Speakers: 

  • Chris Schwartz, Senior Consultant, Blue Matter
  • Jason S. Collins, AIA, Director of Process Architecture, IPS-Integrated Project Services, LLC
Duration: 20 min

Partner Solutions

Single-Use Vs Stainless Steel: Are Hybrid Facilities the Best of Both Worlds?

Speaker: 

  • Lindsay Smart, CEO, ZETA USA Inc.
Duration: 20 min

Partner Solutions

Measurement & Control of Hydrogen Peroxide Bio-Decontamination Cycles

Speaker: 

  • Justin Walsh, Application & Business Development Engineer, Vaisala Inc
Duration: 20 min

Partner Solutions

Systematically Safeguarding Container Closure Integrity

Speaker: 

  • Qingyu Zeng, PhD, Fellow & Technical Director, West Pharmaceutical Services
Duration: 35 min

Partner Solutions

A Data Analytics & AI Driven Approach to Inform Aseptic Processing

Speaker: 

  • Vaibhav Kshirsagar, Technical Product Manager, IMA Life North America Inc
Duration: 20 min

Partner Solutions

3D Bioprinting Suite and Facility Design Considerations

Speaker: 

  • William G. Whitford, Life Science Strategic Solutions Leader, DPS Group
Duration: 20 min

ISPE Best of Pharma Series: Aseptic

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

Buy Now

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