Opening Remarks

Introduction to the conference

Emily Cheah, Chair of the Conference

Regulatory Landscape and Trends
Dinesh Khokal

Moderator: Dinesh Khokal, Amgen

  • Dinesh Khokal (Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen)

    Dinesh Khokal

    Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen
Keynote – Covid-19 vaccine production related
Regulatory forum on sterile manufacturing

FDA and EMA

Panel Discussion and Q&A
Break
Is Pharma ready to be disrupted

Di Morris, AstraZeneca (Invited)
Karen Ginsbury, PCI Pharmaceutical Consulting (Invited)

Implementation challenges of Annex 1 in a global sterile site

Julian Kay, GSK (Invited)

Real time process monitoring

Cenk Ündey, Executive Director (Invited)
Chris Garvin, Principal Engineer (Invited)

Panel Discussion and Q&A
Aseptic Processing Challenges in the Context of Annex 1

The inclusion of PUPSIT in Annex 1 have challenged operations with regards to wording and interpretation; particularly with regards to when and why a risk assessment should be used.

Moderator: Bruce Loxley, GSK

The implications of PUPSIT in Annex 1 revision

Steven Ensign, Eli Lilly (Invited)

Quality risk management principles – PUPSIT

Marjo Peters, Astra Zeneca (Invited)

Use of scientific data to control risks associated with sterilization filtration
Somasundaram G.

Michael Payne, Merck (Invited)
William Peterson, Merck (Invited)
Somasundaram G., Merck (Invited)

  • Somasundaram G. (Senior Consultant Asia Pacific, Process Solutions at Merck KGaA)

    Somasundaram G.

    Senior Consultant Asia Pacific, Process Solutions at Merck KGaA
Panel Discussion and Q&A
Break
New technology / robotics in Sterile Manufacturing Aspects / Barrier technology
Blue Bird Bio

Mitch B. Garber, BS, RPh, Blue Bird Bio (Invited)

Robotics challenges in barrier systems
Morgan Polen

Morgan Polen, Microrite

  • Morgan Polen (Contamination Control Expert at Microrite)

    Morgan Polen

    Contamination Control Expert at Microrite
Break
ValSource Inc.

Hal Baseman, ValSource Inc. (Invited)

West Pharma/ SKAN AG
Terence Lee

Speaker 1: Terence Lee, West Pharmaceutical Services

Speaker 2: Richard Denk, Skan AG (Invited)

  • Terence Lee (Senior Technical Account Specialist at West Pharmaceutical Services)

    Terence Lee

    Senior Technical Account Specialist at West Pharmaceutical Services
Panel Discussion and Q&A
Regulatory Update

Moderator: Emily Cheah, Charles River Laboratories

Inspection Trends

Thomas Arista, FDA (Invited)

How the Cell and Gene Therapy paradigm is driving USP’s microbiology chapters

Don Singer, USP (Invited)

Quality Risk Management, An Update

Kevin O'Donnell, Health Products Regulatory Authority (HPRA) of Ireland (invited)

Panel Discussion and Q&A
Lunch Break
Contamination Control Strategy / Environmental Monitoring
Ziva Abraham

Moderator: Ziva Abraham, Microrite

  • Ziva Abraham (CEO of Microrite)

    Ziva Abraham

    CEO of Microrite
Sterilization

Beth Kroeger, STERIS (Invited)

Mold contamination, Investigations and Remediation challenges
Ziva Abraham

Ziva Abraham, Microrite

  • Ziva Abraham (CEO of Microrite)

    Ziva Abraham

    CEO of Microrite
Break
Contamination Control / Environmental Monitoring
Dona B. Reber

Dona B. Reber, SME Microbiologist, Pfizer Global Operations at Pfizer

  • Dona B. Reber (SME Microbiologist,  Pfizer Global Operations at Pfizer)

    Dona B. Reber

    SME Microbiologist, Pfizer Global Operations at Pfizer
Case Study of Contaminated Water for Injection

Olivier Chancel, Boerhinger Ingelheim (Invited)

Panel Discussion and Q&A
Break
Rapid Microbiology / Automation

Moderator: Emily Cheah, Charles River Laboratories

Presentation

Tim Sandle (Invited)

Rapid Micro Method Application
Jonas Van Den Berg

Jonas Van Den Berg, Roche

  • Jonas Van Den Berg (Global Quality Manager at Roche)

    Jonas Van Den Berg

    Global Quality Manager at Roche
Value of Rapid Micro Methods in a COVID Era

Michael J. Miller, President of Microbiology Consultants, LLC (Invited)

Panel Discussion and Q&A
Closing Session