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SMi Group is proud to present the Pharmaceutical Microbiology Workshop Day...

How to Develop a Risk Based Approach to Cleaning and Disinfection:

This workshop will cover the current industry trends and best practices in disinfectant global regulations, rotation, disinfectant application methods, application frequencies, residue removal and rinsing strategies, disinfectant validation and a case study in bioburden control will be covered. CAPA investigations related to contamination control in cleanroom operations will be covered. Annex I (Draft 2018), FDA Warning Letters, FDA 483s, and PDA Technical Report No. 70 sections will be covered which relate to the topics mentioned.
The workshop will focus on industry trends and industry best practices based on 20 years of global industry experiences.
 

Designing an Environmental Monitoring Programme:

Environmental monitoring has a very limited capability of providing assurance of good hygiene control, therefore it must be optimised, based upon a risk assessment. The workshop will provide information regarding the contamination challenges from the environment, operators, equipment failure and design limitations. In addition, the workshop will discuss the monitoring techniques and instruments used to generate the data and will involve some practical exercises. At the end of the workshop, the delegates will have a clear understanding of the limitations and strengths of environmental monitoring and how to design and execute the monitoring programme.

Rapid Micro Methods, Endotoxin Testing and LER:

The control of objectionable microorganisms and endotoxins in pharmaceutical products is vital to ensure the complete safety from diverse immune reactions associated with exposure. As products become more complex, rapid micro methods and alternative endotoxin testing and LER become more routine and significant, which suggests continuous assessment and validation. This workshop will start with a revision of the current regulatory landscape set by the authorities such as FDA and EMA. Following this will be an examination of the most robust RMMs, the pros and cons associated, and prescribed implementation and validation strategies. The 2nd half of the workshop will survey and compare routine endotoxin testing methods with proposed alternatives. The workshop finishes off with an expert view of how to address LER and a means of evaluating contamination risk.

 

How to Develop a Risk Based Approach to Cleaning and Disinfection:

Key Topics Covered:
• Industry Regulations
• Technologies (Chemistries)
• How to Select the Best Chemistry
• Application Methods
• Frequencies of Sanitizers, Disinfectants, and Sporicides
• Rotation and Rinsing Strategies

Designing an Environmental Monitoring Programme:

The workshop is designed to be beneficial to all levels of people involved in the operation, monitoring and control of aseptic processes. While this will be a structured event, if other topics are suggested by the delegates, the programme can be tailored to meet their requirements. For subject matter experts, this will serve as a refresher event; for those developing their skills, a learning opportunity; and for managers of aseptic manufacturing, it will provide an overview of the process their staff are required to undertake to support such operations. Ideally delegates should come from the Production, Quality and Engineering departments associated with the manufacture, monitoring and control of aseptically manufactured products.

Rapid Micro Methods, Endotoxin Testing and LER:

Know the benefits of alternative and rapid microbiological methods in regards to the compandia methods.
Understand the science and regulatory aspects of RMM
Learn more about the proposed alternatives for endotoxin detection
Understand Low Endotoxin Recovery impact and how to test

Cleanroom Managers
QA, QC Managers
Validation Managers
Operations Managers
Regulatory Affairs Managers
Lean Managers
Technical Service Managers
Training Managers
 

Allergan Biologics Ltd; Allergy Therapeutics; Allergy Therapeutics UK; AllergyTherapeutics; AstraZeneca; Atalmedial; Baxter Healthcare Ltd; Biomerieux; bioMerieux UK Limited; Boehringer Ingelheim; BPL; British America Tobacco; Cancer Research UK; Cell and Gene Therapy Catapult; Ceutiqus; CGT - Catapult ; CGT (Cell & Gene Therapy Catapult) ; ChargePoint Technology; Charles River; Copan Italia SpA; Dupont De Nemours (Luxembourg) S A; DuPont de Nemours Luxembourg sarl; Fresenius Kabi; Fresenius Kabi UK Ltd; Fujifilm Wako Chemicals USA Corp; Genzyme Geel; Greiner Bio-One; GSK; GSK Vaccines; International Serum Industry Association; Ipsen; Kings College London; MeiraGTx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; Microrite, Inc.; Novo Nordisk; Oak Zone Biotech; Pharmaceutical and Healthcare Sciences Society; Roche Diagnostics Deutschland GmbH; Royal Free Hospital; RSSL; Sanofi; Sanofi Pasteur; Steris Corporation; Synthon Chile; TEVA Runcorn; Teva UK Ltd; The LFB Group; University of Southampton; University of Veterinary Medicine Vienna; zac vventures inc;
 

Workshop programme

8:30 Registration & Coffee

8:50 Workshop Leader's Opening Remarks

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

9:00 A Risk-Based Cleaning and Disinfection Program

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

• Cleaning and Disinfection Methods and Frequencies
• Disinfectant Rotation
• Rinsing and Residue Removal Frequencies
 

9:35 Bringing the Cleanroom Online After a Worst-Case Event

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

• Cleaning Steps Cleanroom Control
• Triple Cleaning Methods and Case Study
• Cleanroom Utilities and Operations Online
 

10:10 Morning Coffee

10:30 Disinfection Validation

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

• Requirements for Manufacturers
• Requirements for Pharmaceutical, Biotech, and Medical Device Industries
• Case Studies in Disinfectant Validation
 

11:05 Continuation of Disinfectant Validation and Contamination Control Case Studies

James N. Polarine Jr

James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
View Bio

• Overview of Disinfectant Validation
• Case Studies in Contamination Control
• Methods to Proactively Prevent Bioburden from Entering Cleanrooms
 

11:30 Session Recap

11:40 Networking Lunch

12:40 Opening remarks and introductions

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

12:50 Designing and Environmental Monitoring Programme: Regulatory History

• A brief introduction to history of the regulations governing the manufacture of sterile parenteral products and providing some examples of regulatory findings with regard to non-compliance.
• Delegates should leave with a clear understanding of the very important but subtle difference between written regulatory guidance and regulatory expectations and the legal framework supporting the regulatory environment.
 

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

13:35 Environmental Monitoring In Context

• This session will focus on the limitations of environmental monitoring and discuss the fundamental aims of using EM to provide a level of assurance that good aseptic control is being maintained. Stress will be placed on the need for good design and operations of a facility to give credence to EM data and decisions that may result from that data interpretation.

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

14:10 Microbiological Monitoring Equipment and Media

This session will focus on the monitoring equipment and media used providing an insight to the techniques used in the monitoring process. The session will include some fundamental microbiology to put the monitoring and media into context. This will merge with session 4 which will be a fully interactive.

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

14:45 Design of An Environmental Monitoring Programme

• This will be a fully interactive session which will involve designing an environmental monitoring programme based on a generic facility design using risk assessment. A range of props will be provided and delegates will be on their feet for most of the time working in small teams.
• This workshop will enable delegates to leave with an understanding of the strengths and limitations of an environmental monitoring programme and how to design one. It will put the data generated into a regulatory compliance context.
 

Ian Symonds

Ian Symonds, Director, Pharmaceutical Consultant, SDA Pharma

Michael Davies

Michael Davies, Director, Independent Pharmaceutical Consultant, SDA Pharma Ltd

15:30 Afternoon Coffee

15:55 Rapid Micro Methods, Endotoxin Testing and lER

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

16:00 Update on RMM Regulation

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

16:35 Evaluating and validating the best RMM Application based on Your Needs

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

17:10 Afternoon Tea

17:30 Endotoxin Detection

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

18:05 LER

Felix A. Montero- Julian

Felix A. Montero- Julian, scientific director, BioMerieux Marcy L'Etoile

18:40 Closing remarks

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VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

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.
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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

HOTEL BOOKING FORM

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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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