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SMi proudly presents the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference being held in London on 6 - 7 October 2021.

It is a critical time for cleanrooms as new regulations in GMP enter their final drafts after several months in review. This conference will explore the forecasted impacts of the new regulations across the pharmaceutical cleanroom industry, from designer to operator.

These significant updates will be influential in the regulatory procedure across the cleanroom industry and come at a time when the global cleanroom technologies market is set to surpass GBP 3 billion in value.


This rapidly growing industry sustains an identical rate of evolution; technological leaps in airflow visualisation and environmental monitoring provide deeper insight into cleanroom management and contribute to the increasing standards in sterility. Additionally, the development of entirely new medicines is forcing new regulatory measures into play.


The agenda will look deeply into the influence of the developments in Annex 1, ISO 14644 and GMP compliance, as well as insights into the novel technologies surfacing in this industry, from robotics and automation to isolator technology implementation.


We look forward to welcoming you to the conference in October.

This workshop will give guidance on how to set limits in applying ISO and EN Standards to Non-Viable and Viable Environmental Monitoring in the context of GMP Cleanrooms and the new Annex 1 guidance and a Contamination Control Strategy.
 

The integrity of cleaning and disinfection programmes is essential in meeting the specified cleanroom contamination grades, to minimise both the cross contamination and microbial contamination of products. A product that is contaminated cannot enter the supply chain without having significant consequences for the manufacturer. Annex 1 was first added to the EU GMP in 1989 and outlined specific protocol for the production of sterile medicinal pharmaceuticals. Given the advances in the pharmaceutical industry, a full revision of the annex is overdue, yet a complete review of the document has not been conducted for over a decade. This workshop will review the significant updates in regulatory expectation at a critical time in the cleanroom industry.

Heads, Managers, Directors, Experts:

  • Microbe Monitoring
  • Contamination control
  • Aseptic Processing
  • Cleanroom Technology
  • Microbiology
  • Sterility Assurance
  • Environmental Monitoring

3dimension Cleanrooms Limited; ALK-Abello Nordic A/S; Allergan Biologics Ltd; Alpha RLH; ASCCA (Italian Cleanroom Society); AstraZeneca; Baxter Healthcare Ltd; Bio Products Laboratory Ltd; BIOMÉRIEUX AUSTRIA GMBH (PO6500579899); BioTekPro AB; Boehringer Ingelheim; Boehringer Ingelheim Animal health; Charles River EMD; Contec; Contec Inc; Contec Incorporated; DEERNS S.L; Dupont De Nemours (Luxembourg) S A; Ecolab; EECO2 Ltd; Fresenius Kabi; Fresenius Kabi Product Partnering ; Fresenius Kabi UK Ltd; GSK; Imperial College London; Kings College London; MeiraGTx; PHSS: Pharmaceutical & Healthcare Sciences Society; Porton Biopharma Limited; Porton Biopharma Ltd; Royal Free London NHS Trust; STERIS Corporation; Takeda; Techniconsult Firenze SRL; VCCN;
 

Workshop programme

8:30 Registration & Coffee

9:00 Opening remarks and introductions

Conor Murray

Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
View Bio

9:10 Part 1. Applying ISO and EN Standards to Environmental Monitoring in the context of Annex 1

Conor Murray

Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
View Bio

• New Annex 1 focus on QRM and a Contamination Control Strategy (CCS)
• Principles of establishing and demonstrating control, aligned to Annex 1
• Application of the new EN 17141 on biocontamination control to Viable EM
• Application of ISO 14644-2:2015 to Non-Viable EM

10:30 Morning Coffee

11:00 Part 2. Applying ISO and EN Standards to a CCS in GMP Cleanrooms

Conor Murray

Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
View Bio

• Applying QRM and choosing the most appropriate locations
• Intelligent decision making based on the EM data

12:20 Closing Remarks

Conor Murray

Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
View Bio

12:30 End of workshop

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FEATURED SPEAKERS

Conor Murray

Conor Murray

Principal Consultant, 3dimension Cleanrooms Limited

Conor Murray

Principal Consultant, 3dimension Cleanrooms Limited
Conor Murray

Conor Murray has over 30 years’ experience in design and construction of cleanrooms andbiosafety labs, and since 2007 independently in an oversight and auditing role.Conor represents the National Standards Authority of Ireland (NSAI), as Head of Delegation and a SME at ISO/TC209 and the European mirror CEN/TC243 on cleanroom standardisation. Conor is a past Convenor of CEN/TC243 WG-05 on biocontamination control and the recently published EN 17141 standard. Conor is the Chair of the Healthcare Services Committee advising the Irish Health Service Executive on standards compliance. Conor is Chair of the Irish Cleanrooms Society (ICS) and a past Chair of the International Confederation of Contamination Control Societies, (ICCCS). Conor lectures internationally and gives cleanroom training and education courses on behalf of the ICS.
 

VENUE

Venue To Be Confirmed

London, United Kingdom

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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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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