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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.

 

The 21st century paradigm of cGMP has been marked by a transition away from rule-based compliance, toward risk-based. As a result, risk assessments are increasingly commonplace in the pharmaceutical industry. Now, the revised EU Annex 1 highlights the GMP requirement for risk assessments to support nearly all aspects of the Contamination Control Strategy. But standard risk assessment tools are difficult and time-consuming to execute well, and the outcomes are often criticized for being highly variability and delivering non-compliant conclusions. There is a need for novel risk tools that are: simple to use, steering to robust conclusions, and easy to explain in inspection.

This workshop will introduce a novel tool that shows the overall risk profile for a holistic Contamination Control Strategy. The material will be delivered Jon Williams, Sanofi’s leading global risk expert and Cheryl Essex, Sanofi’s lead contamination control expert, who co-developed the novel CCS risk tool being shared.
 

This workshop will allow participants to:

- execute a novel risk tool that is user-friendly and useful to draw compliant conclusions, drive continuous improvement, and present a holistic profile of contamination risk to internal stakeholders and external regulatory inspectors

- envision how to adapt the design and methodology of the novel risk tool for their own applications - avoid pitfalls of risk management approaches

 

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)

13:30 Opening Remarks and Introductions

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

13:40 Background: The drawback of standard risk tools for contamination control

- Drawing compliant conclusions
- Driving continuous improvement
- Presenting a holistic risk profile to internal and external stakeholders 

 

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

14:00 Executing the new holistic contamination control risk tool

• Drawing compliant conclusions
• Driving continuous improvement
• Presenting a holistic risk profile to internal and external stakeholders
 

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

15:15 Coffee Break

15:45 Adapting the methodology of the holistic risk tool for other applications

- Guidance in utilising new risk-based tools for individual needs

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

16:20 Avoiding common risk management pitfalls

- Reflections on industry challenges
- Toolbox for future-proof adaptations
 

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

16:50 Closing Remarks

17:00 End of Workshop Day

Cheryl Essex

Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
View Bio

Jon Williams

Jon Williams, Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
View Bio

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FEATURED SPEAKERS

Cheryl Essex

Cheryl Essex

Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH

Cheryl Essex

Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
Cheryl Essex

Ms. Essex is the recognized expert in Microbial Contamination Control for Sanofi Biologic manufacturers. She leads a committee of Microbial Control leaders from across the global Sanofi network. She has 15 years’ experience in Contamination Control and Microbiological Quality Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human stem cell systems. Ms. Essex holds degrees in Biology with a Microbiology focus and Bioengineering. She has built strong technical expertise in all aspects of contamination control including facility, utility, and process design, and cleaning validation. Over the last 5 years, she has worked alongside Quality Risk Management leaders at Sanofi Genzyme to build novel risk tools that are targeted at enhancing contamination control programs.

Jon Williams

Global Proactive Risk Manager, Sanofi-Aventis Deutschland GmbH
Jon Williams

Jon Williams is a member of the Sanofi Global Quality Risk Management (QRM) team tasked with designing, executing and growing the vision and strategy for QRM across the Sanofi manufacturing organization. The team creates harmonized practices targeted at anticipating and avoiding unacceptable risk based on ICH Q9 principles. Specifically, Jon supports manufacturing sites in the implementation and integration of QRM principles throughout the site quality organization including training on established risk tools (e.g. PHA, FMEA, HACCP) and the development of new tools.

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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

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