Six key Microbiology presentations from FDA, STERIS, Boehringer Ingelheim Microbiological Consulting, Parexel

On Jan 22, 2021

SMi Group Reports: Six key microbiology presentations from FDA, STERIS, Boehringer Ingelheim Microbiological Consulting, Parexel will be discussed at SMi’s 4th Annual Pharmaceutical Microbiology East Coast Conference, which will convene as a virtual conference on April 28th and 29th, 2021 and the pre-conference virtual workshops on April 27th, 2021.

Six key presentations will be covered at the 2021 East Coast Pharmaceutical Microbiology Conference by Boehringer Ingelheim, FDA/CDER, Microbiological Consulting, LLC, STERIS Corporation, FDA and Parexel sessions, the presentations will cover sterility regulation and guidance, microbial risk based detection, monitoring water systems and contamination control.

The conference brochure has been updated, download online to see the full agenda and speaker line-up www.microbiologyeastcoast.com/PJPR2

Manufacturing facility assessments during COVID Pandemic, covering:
Introducing the changes to the manufacturing facility assessment to support application required in light of the COVID Pandemic
Insight into how the FDA CDER Office of Pharmaceutical Quality has evolved its approaches to continue manufacturing facility assessments
Recommendations to manufacturers for a successful remote manufacturing facility assessment
Commander Qiao Bobo, Division Director, Office of Pharmaceutical Quality, FDA/CDER

Emergency Use Authorization: Understanding a Regulatory Strategy Weapon Used to Battle a Pandemic, covering:
Describing EUA approaches developed by global regulatory health authorities
Understanding how EUA authority could be applied
Case studies: Application of EUA authority to combat COVID-19
Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel

Live, Stressed, and Dead Microorganisms – Their Role in Microbial Test Method Validation, covering:
The effects of different stress factors, i.e., heat, starvation, growth phase, extreme pH, osmotic stress, antimicrobial agents, etc. on representative microorganisms
These stress factors will be related to manufacturing processes and drug product attributes; simulating these stresses with candidate study protocols
Emphasising the continuum from repairable cell damage, loss of cell viability to cellular death
Reviewing the role of repair mechanisms to damage to cell membrane function, enzymatic activity, protein synthesis and nucleic acids in terms of the recovery and enumeration of microorganisms using growth and non-growth methods
A case will be made that use of stressed microorganisms as challenge organisms in method validation, suitability testing and growth production testing is not necessary
Dr. Tony Cundell, Principal Consultant, Microbiological Consulting, LLC

A Risk Based Cleaning and Disinfection Program, covering:
Addressing Cleaning and Disinfection as a critical component of a contamination control program during a pandemic
Discussing current regulations, disinfectant and sterilant technologies, and operator safety in-depth
Insight into global regulatory expectations: FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, and ANSM
Assessing critical industry guidance documents: Annex I, USP 43 <1072>, PDA Technical Report #70
Best practices in designing an effective risk-based program and understanding current industry trends regarding cleaning and disinfection
Current industry FDA Warning Letters and FDA 483s
Jim Polarine, Senior Technical Service Manager, STERIS Corporation

Common Issues in The Sterility Assurance Assessment, covering:
Introduction to FDA small molecule microbiology/ manufacturing
Common deficiencies seen in applications
Recommendations for applications to expedite approval
John Arigo, Director, Division of Microbiology Assessment, FDA

ENDOTOXIN TESTING SPOTLIGHT SESSION – Automating Endotoxin water monitoring at Boehringer Ingelheim with Endosafe® Nexus™ – A business and validation perspective, covering:

Build your business case to show the impact of automation in your lab

Why is an economic assessment necessary?
Definition of financial parameters for your business case
Case study: business case of water monitoring with Endosafe® Nexus™ at BI
Define your validation strategy
Match the technology to the right application: water monitoring
Validation approach for automated compendial methods
Case study: validation of water monitoring with Endosafe® Nexus™ at BI
The Endosafe® Nexus™ in routine
The importance of monitoring your automated rapid microbiological method
A look at the operating performance of Endosafe® Nexus™ units installed at BI
Benefits and opportunities of Endosafe® Nexus™ from BI perspective

Johannes Oberdörfer, Scientist, Rapid Microbiology Methods, Boehringer Ingelheim

This event is ideal for those who are interested and work as Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist, Analytical Standards Specialist.

For more information on the conference visit www.microbiologyeastcoast.com/PJPR2