Home
overview

For the latest COVID-19 Travel restrictions and recommendations please click here

SMi’s 5th Annual Conference
Pharmaceutical Microbiology West Coast
June 16th – 17th, 2022 | San Diego, California
-------------------------------------------------------------------------
The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, and novel testing methods, this industry is ever expanding.

Join industry experts to discuss the latest topics and pressing challenges in this field. Network with professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations and approaches for conventional and rapid microbiology methods, discuss optimised environmental monitoring to best control contamination and gain insight into an industry perspective on alternative endotoxin testing methods and process automation, all contributing to better management of contamination in biopharmaceutical manufacturing.

We look forward to welcoming you to the conference.

 

  • Share expert guidance and explore the regulations concerning objectionable organisms in drug products
  • Gain insight into changing paradigms in the field, from in-process testing to digitalisation
  • Explore alternative endotoxin test methods and rapid microbiological testing
  • Evaluate the best practices and most common pitfalls within microbial detection and elimination
  • Dissect the framework of a robust Global Contamination Control Program and how t approach implementing a holistic CCS 

 

Chief Executives, Vice Presidents, Directors, Heads of Department, Senior Managers, and Principal Scientists specialising in: 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; Operations Managers; Heads of Site Compliance; Heads of Sterile Technology; Global Microbiology Analytical Experts; Cleanroom Managers; Regulatory Affairs Managers; Production Managers; Quality Systems Managers.

 

Abbott Laboratories; Advanced Sterilization Products (J&J); Ajinomoto Althea, Inc.; Allergan; Althea; Amneal Pharmaceuticals; Associates of Cape Cod; Association of Cape Cod, Inc; AstraZeneca; Atara Biotherapeutics; Battelle Memorial Institute; Bayer Healthcare; Bimeda; Biofiredx; Biomerieux; bioMerieux Industry; Bioscience International; BioVectra Inc; BioVigilant Systems; Charles River; Charles River Laboratories; Fujifilm Wako Chemicals USA Corp; Genentech; Genentech Inc; Genentech, Inc; Gilead Sciences; Grifols Biologicals; Janssen; Lonza Walkersville, Inc.; Mettler Toledo; Microbiologics; Microrite Inc.; Microrite, Inc.; Millipore Sigma; Morphotek, Inc.; Mycoplasma Biosafety Services GmbH; Northstar Medical Radioisotopes; Novatek International; QuVa Phama; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Revance Therapeutics; Roche; San Diego State University, Women in Science Society; Steris Corporation; Takeda Pharmaceutical Company Limited; Teva Pharmaceuticals; UCSD; Ultragenyx Pharmaceutical; University of California San Diego; University of New England; University of Veterinary Medicine Vienna; Vital Therapies; Xellia Pharmaceuticals;
 

Conference programme

8:00 Registration & Coffee

9:00 Chair's Opening Remarks

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

9:10 Annex I Revisions Affecting Cleaning and Disinfection and Contamination Control

Jim Polarine Jr.

Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation

• Pass-thru decontamination procedures will be covered.
• The current industry stance on disinfectant rotation will be discussed.
• A roadmap to an effective contamination control strategy will be covered.
• Disinfectant Validation and RABS disinfection will be covered utilizing case studies

9:50 Cutebacterium acnes contamination, becoming more visible as biologic contaminant

Kenneth Boone

Kenneth Boone, Associate Director, Merck

• Ensuring the continuous confirmation of controlled conditions and the assessment of microbial risks
• Demonstrating how personnel are the major source of microbial risks in controlled cleanroom environments
• Revealing the modern metagenomic analytical methods that have identified a greater abundance of C. acnes
• Delving into C. acnes culture medium, incubation conditions, effective monitoring, and ultimate controls

10:30 Morning Coffee

11:00 Points to consider when defining a microbial control strategy for individualized ATMPs

Friedrich von  Wintzingerode

Friedrich von Wintzingerode, QC Lead iNeST Project individualized Neoantigen Specific Therapy, Genentech, Inc

• How are individualized ATMPs different to traditional drugs and off-the-shelf ATMPs?
• Regulatory background
• Microbiological testing: be smart and keep it simple
• The importance of raw material control
• ATMPs: A mindset challenge for Microbiologists

11:40 Aseptic processing and contamination control strategies for cell therapies

Elia Sanchez

Elia Sanchez, Associate Director, Allogene Therapeutics

• From facility construction to clinical runs
• Aseptic process simulation studies
• Risk assessment and contamination control strategy

12:20 Networking Lunch

13:20 Commercial Cell Therapy Experience using Mycoplasma NAT for Product Release: Five-Year Review

John Duguid

John Duguid, Senior Director, Research & Development, Vericel Corporation
View Bio

14:00 Points to Consider: Demonstrating Equivalence Between Compendial and Alternative Methods for Endotoxin Testing

Karen McCullough

Karen McCullough, Principal Consultant, MMI Associates, LLC

• Why demonstrate equivalence?
• What is the definition of an alternative method for the detection and quantitation of endotoxins activity?
• What is the difference between statistical equivalence of a method and product specific suitability testing?
• What is the role of the calibration standard in method validation?

14:40 Afternoon Tea

15:10 Contamination Control – Blurring the Dichotomy of Sterile and Non-sterile Manufacturing

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

• Holistic approach to contamination control supports the pharmaceutical microbiologist
• Value of both USP <1115> and <1211> for an integrated approach
• Microbiological control in cell therapy manufacture teaches us about balance for patient safety
• How risk assessment guides us to the critical point(s) for product/patient safety

16:20 Topic Heading 8

17:00 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

9:10 Novel approach to cleanroom disinfection

9:50 Pharmaceutical microbiology and the ongoing impact of the pandemic on supply chain

10:30 Morning Coffee

11:00 Harmonized Manufacturing Network for Sterility Assurance

Frederic Ayers

Frederic Ayers, Research Scientist, Eli Lilly and Company
View Bio

• Global guidance related to Contamination Control Strategies
• Experience and perspective from a site sterility assurance lead
• Developing new sterility assurance processes to both active and future facilities
• Managing regulatory interactions and leading successful audits: past examples

11:40 Holistic Contamination Control Strategy (CCS) Development in Pharmaceutical Manufacturing

Biswarup DasGupta

Biswarup DasGupta, Director, Quality Assurance, Gene Therapy, Sarepta Therapeutics
View Bio

• The development and documentation of the Contamination Control Strategy is viewed by many as the most difficult new requirement in the Annex 1 revision
• This session will address how to fulfil this requirement, with a discussion on the expectations from regulators and practical advice derived from industry experience

12:20 Networking Lunch

13:20 Removing the risk – experiences in qualification of a fully robotic isolator for aseptic filling of sterile drug product

Joseph McCall

Joseph McCall, Associate Director, QA Technical Service , ADMA Biologics

• Case Study on commissioning of a new aseptic fill line – comparing conventional aseptic filling systems to the next-gen gloveless isolators
• Customer experience – insights on moving to fully enclosed robotic isolators
• Contamination Control – What it means to remove the Fill Room Operator
• Industry Impact - Agility and Next Steps to the future of aseptic filling

14:00 Panel Discussion: The Future Face of Pharmaceutical Microbiology

• The ramifications of personalised, small batch, short-lived therapies
- Considering the modifications to general GMP required when processing ATMPs
- The challenges associated with meeting Quality Risk Management requirements when handling cell therapies
• The evolving landscape of QA and QC in pharmaceutical manufacturing
- The advantages of international and intercompany collaboration when developing future pharma modalities
- What does Pharma 4.0 mean for Pharmaceutical Microbiology
• How the ongoing pandemic has tested manufacturers and suppliers, and driven market growth
- Maintaining an interface between Operations, Quality, and Drug Product Manufacturing

Jim Polarine Jr.

Jim Polarine Jr., Senior Technical Service Manager, STERIS Corporation

John Duguid

John Duguid, Senior Director, Research & Development, Vericel Corporation
View Bio

Friedrich von  Wintzingerode

Friedrich von Wintzingerode, QC Lead iNeST Project individualized Neoantigen Specific Therapy, Genentech, Inc

14:40 Afternoon Tea

15:40 Topic Heading 7

16:20 Topic Heading 8

17:00 Chairman’s Closing Remarks and Close of Day Two

+

FEATURED SPEAKERS

Biswarup DasGupta

Biswarup DasGupta

Director, Quality Assurance, Gene Therapy, Sarepta Therapeutics
Donald Singer

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, Ecolab
Frederic Ayers

Frederic Ayers

Research Scientist, Eli Lilly and Company
Jim Polarine Jr.

Jim Polarine Jr.

Senior Technical Service Manager, STERIS Corporation
Joseph McCall

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Karen McCullough

Karen McCullough

Principal Consultant, MMI Associates, LLC

Biswarup DasGupta

Director, Quality Assurance, Gene Therapy, Sarepta Therapeutics
Biswarup DasGupta

Biswarup DasGupta (Bis) is a Quality and Compliance leader leading cross-functional teams in Manufacturing, Quality Control, and Quality Assurance over 20 years. During this period, Bis has successfully led Consent Decree (CD) Verification, Certification Inspection by FDA. His professional strengths are Development, Remediation, and Implementation of Quality Systems, Aseptic Processing, Contamination Control and Compliance with CGMP, Training and mentorship, Pre-Approval Inspection (PAI) Preparation, Internal Audits, Method and Equipment Validation, Project Management, and Quality Risk Management. He has experience in both large and small molecules (both pharma and biotech including Gene therapy) drugs. Bis is actively involved with PDA, co-authored PDA TR 13-2, and currently co-leading the new PDA TR on Contamination Control. Before Sarepta, Bis worked with Sanofi, GSK and other companies with increasing responsibilities.

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, Ecolab
Donald Singer

Elia Sanchez

Associate Director, Allogene Therapeutics
Elia Sanchez

Frederic Ayers

Research Scientist, Eli Lilly and Company
Frederic Ayers

Biography:
Fred graduated with a Bachelor of Arts (B.A.) degree in Biology from Franklin College of Indiana in 1999, while being a student-athlete and participating in the college’s Leadership Program. After graduating, he spent two-years working in the pharmaceutical and food contract manufacturing industries. In 2001, Fred joined Eli Lilly and Company as a microbiologist in the Quality Control Laboratories. During his career with Lilly, Mr. Ayers has held various quality and technical positions of greater responsibilities. He has helped advance Lilly's state of regulatory compliance through strong depth and breadth of technical knowledge, and his strong industry network. Fred is the Sterility Assurance subject matter expert for the Indianapolis Parenteral Manufacturing site with the responsibility of driving continuous improvement and collaboration to ensure alignment and network harmonization. He also leads a cross-functional team evaluating the site’s key process indicators to ensure optimal contamination control performance. Additionally, Mr. Ayers has been a PDA Midwest Chapter Board Member since 2014, and has been the chapter’s President Elect / President from January 2018 through December 2021.
 

Friedrich von Wintzingerode

QC Lead iNeST Project individualized Neoantigen Specific Therapy, Genentech, Inc
Friedrich von  Wintzingerode

Jim Polarine Jr.

Senior Technical Service Manager, STERIS Corporation
Jim Polarine Jr.

John Duguid

Senior Director, Research & Development, Vericel Corporation
John Duguid

JOHN DUGUID is Senior Director, Research & Development at Vericel Corporation. As
a Principal Scientist at Genzyme, he was responsible for developing and implementing
rapid microbiological assays and had previously managed QC cell therapy operations.
Prior to Genzyme, he worked as an analytical chemist at Abbott Laboratories and Arthur
D. Little. Mr. Duguid received his BS in Chemistry from the University of Michigan.

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Joseph McCall

Karen McCullough

Principal Consultant, MMI Associates, LLC
Karen McCullough

Exhibitors

VENUE

Venue to be confirmed

San Diego, USA

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Exhibitors


Associates of Cape Cod

Exhibitors
http://www.acciusa.com/acc/index.html

Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1- > 3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


Bioscience International

Exhibitors
http://www.biosci-intl.com

The newest generation of SAS microbial air monitors, for ensuring full compliance with ISO 14698, cGMP and other international monitoring guidelines will be displayed.

SAVE TO


Outlook Calendar  OUTLOOK CALENDAR
Google Calendar  GOOGLE CALENDAR
ICal Calendar  ICAL CALENDAR
Yahoo! Calendar  YAHOO! CALENDAR

Venue to be confirmed

San Diego
USA

Venue to be confirmed

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.

Thank you for visiting our event

If you would like to receive further information about our events, please fill out the information below.

By ticking above you are consenting to receive information by email from SMi.
Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out