SMi is proud to announce the 4th Annual Pharmaceutical Microbiology East Coast Virtual Conference taking place on April 28th – 29th, 2021.

The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, innovative approaches in ATMP facilities, this industry is ever expanding. Join leading experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation.


This workshop will be interactive while sharing the latest revisions and proposed revisions from the USP Microbiology Expert Committee. Some areas that will be discussed are sterilization, disinfectant efficacy testing, bacterial endotoxins test, B. cepacia test, microbial ‘sterility’ test for ATMPs, and microbiology best laboratory practices.
Bring your questions and learn how to use/interpret the USP microbiological information and standards with a member of the Expert Committee.

• Learn the latest revisions in USP
• Learn the latest proposals in the USP PF
• Opportunity to discuss your questions directly with an Expert Committee member
• Opportunity to suggest new ideas to an Expert Committee member


Validation Managers
Quality Control Managers
Quality Assurance Managers
Lean Managers
Operations Managers
Cleanroom Managers
Regulatory Affairs Managers
Production Managers
Quality Systems Managers



Amneal Pharmaceutical; Amneal Pharmaceuticals LLC; Analytical Lab Group LLC; Associates of Cape Cod; Association of Cape Cod, Inc; Atara Biotherapeutics; Banelle; Baxter Corporation; bioMerieux Industry; bioMerieux, Inc.; Bioscience International; BioTekPro AB; Biotherpeutics; BioVigilant Systems; Bristol Myers Squibb; Charles River; CTL - Mat; DuPont; DuPont de Nemours Luxembourg sarl; Dupont Personal Protection; Eagle Analytical Services (Former FDA); Eli Lilly And Company; Emergent Biosolutions; Genentech; ImmuneBiotech AB; Infinity Laboratories; InnovaPrep; International Serum Industry Association; Ipsen; Lantheus Medical Imaging; Lonza; Lonza Walkersville, Inc.; Merck; Meridian Medical Technologies; Mettler Toledo; Microbiological Consulting, LLC; Microrite, Inc.; Novartis Pharmaceuticals Corporation; Novatek International; Ocular Therapeutix; Organogenesis Holdings Incorporated; Pfizer; Pfizer Inc; Pharmaceutical and Healthcare Sciences Society; Pharmalucence, Inc.; Regeneron; Regeneron Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme; SCA Pharma; Seres Therapeutics; Steris Corporation; Sun Pharma Boston; Takeda; Takeda Pharmaceuticals; United Therapeutics; University Of Calgary; University Of Guelph; University of Veterinary Medicine Vienna; Vericel Corporation; Zeteo Tech LLC;


Workshop programme

All timings are in Eastern Daylight Time (BST-5)

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

9:10 How Do I Best Use the USP?

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

- Monographs and General Notices
- Benchmarking with General Information
- Standards, Resource, Teaching Tool

9:40 Latest Proposed Revisions in USP PF

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

- Tests for ATMPs
- Microbiology Best Laboratory Practices <1117>
- Disinfectant Efficacy Testing <1072>
- Alternative Bacterial Endotoxin Testing <1085.1>

10:20 Coffee Break

10:50 Latest Revisions in USP45 and Beyond

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

- B. cepacia Test <60>
- Sterilization topics <1229.16> <1229.17>
- Guidelines on Bacterial Endotoxins Test <1085>

11:30 New Activities and Innovative Committee Thinking

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

- Containment and Contamination Control Monitoring
- Alternative Microbiological Tests and Comparability
- Will the Real Objectionable Microorganism Stand Up?

12:10 Closing remarks

Donald Singer

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
View Bio

12:20 Networking Lunch



Donald Singer

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
Donald Singer

Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member of this committee since 2000. Don is a member of the European Pharmacopeia Group 1 Microbiology Committee. He is also chair of the PDA Task Force for the revision of Technical Report titled, “Pharmaceutical Package Integrity Testing”, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is also an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.


Online Virtual Event

Online Virtual Event , 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.


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

Online Virtual Event

Online Virtual Event

Online Virtual Event



speaker image






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.


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.


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.


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


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
Forgotten Password?


UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, 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