remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.
Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.
On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology
methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding - join leading experts in 2023 to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology
. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.
Benefits of Attending
- EXPLORE innovative contamination control strategies for cell & gene therapies and personalised medicines to ensure product quality and patient safety
- REVIEW case studies on the implementation and validation of modern, rapid microbial testing methods for effective quality by design
- EMPLOY effective contamination control in your manufacturing facility by benchmarking strategies with representatives from Boehringer Ingelheim, Takeda and GSK
- LEARN how to control, identify and disinfect cases of mold contamination and ensure your disinfectant programme meets regulatory expectations
- DELVE into the role of microbiologists in combination product manufacturing and how parametric release and holistic closure integrity testing can ensure a contaminant free product
Who should attend
- Heads of Aseptic Processing
- Heads of Microbiology
- Global Quality Directors
- Heads of GMP Compliance
- Quality & Compliance Heads
- Microbiology Senior Specialists
- Directors of Quality Control Biology
- Quality Control Managers
- Quality Assurance Managers
- Lean Managers
- Operations Managers
- Heads of Site Compliance
- Heads of Sterile Technology
- Global Microbiology Analytical Experts
- Cleanroom Managers
- Regulatory Affairs Managers
- Production Managers
- Quality Systems Managers
- Alison Laughlin, Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
- Austin Kuo, Senior Director - Sterility Assurance - TS/MS, Eli Lilly
- Donald Singer, USP General Chapter Committee Microbiology Chair, US Pharmacopeia
- Erika Pfeiler, Quality Assurance Lead, FDA
- Gurpreet Ganda, Senior Manager, QC Microbiology, Roche
- Hilary Chan, Principal Quality Control Scientist, Takeda
- Jason McGuire, Vice President, Global Quality, Fagron
- Jim Polarine, Senior Technical Service Manager, Steris Corporation
- John Arigo, Division Director, FDA
- John Duguid, Executive Director, Research & Development, Vericel Corporation
- Kenneth Paddock, Quality Director, Sterility Assurance, Baxter
- Kim Sobien, Contamination Control Lead:, GSK
- Laurie Boyd, Senior Microbiologist/Team Leader, Alkermes, Inc.
- Li Wei Chan, Manager Microbiology, MSD Pharma (Singapore) Pte Ltd
- Liz Brockson, Aseptic Processing and Sterility Assurance Lead, Takeda
- Michael Song, Associate Director, Takeda Pharmaceuticals
- Shelton Sparks, Product Manager Testing Solutions, Lonza
Please fill in your name and email to receive the Conference Agenda of this event.
VenueCourtyard by Marriott Boston Downtown
275 Tremont St, 02116
Boston, MA, USABook your Room here
Preferential rate is $279
Amenities includes complimentary Wi-Fi, and 24 hour access to our fitness center.
*Breakfast not included.