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This workshop will cover the legal basis for establishing ADEs/PDEs and for conducting risk assessment for preventing cross-contamination in multi-product pharmaceutical manufacturing facilities. In addition, the instructor will cover 10 misconceptions regarding OELs/ADEs/PDEs.

If your facility handles multiple products, understanding these requirements and how they are implemented is a must. Facilities that have not complied with these requirements have experienced enforcement action and market suspensions.

Abzena; ADC Biotechnology; Antikor Biopharma Ltd; Antikor Biopharma Ltd.; AS-Tec Chemicals Ltd; AstraZeneca; Cancer Research Technology Ltd; Cancer Research UK; CARBOGEN AMCIS AG; Cfm Oskar Tropitzsch e.K.; Crescendo Biologics Ltd; Endocyte, Inc.; Heraeus Precious Metals GmbH & Co. KG; Immunogen; King's College London; Lonza Ag; Medimmune; MedImmune Inc; Menarini Ricerche; Merrimack Pharmaceuticals Inc; MRC Technology; NBE Therapeutics; Novartis Biologics; Novasep; Oncotec Pharma Produktion GmbH; Pfizer; Piramal Pharma Solutions; Roche Pharmaceuticals; Schering; Sigma-Tau Industrie Farmaceutiche Rimile SpA; SKAN AG; Syndivia; Takeda Pharmaceuticals; The University of Bath; Thomson Reuters; UCL; University College London; University Of Bath;

Workshop LEADER

keynote-img

Dean Calhoun

President / CEO, Affygility Solutions

Dean Calhoun is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). He has been an environmental health and safety professional for over 30 years.
Prior to starting Affygility Solutions, Dean was the Associate Director of Environmental Health and Safety for Gilead Sciences, Inc., a biopharmaceutical company focused on developing pharmaceuticals for infectious, viral, and oncology applications. His experiences including development and implementation of global EHS guidelines, implementation and coordination of an executive management EHS Steering Committee, establishment of occupational exposure limits for pharmaceutical active ingredients, industrial hygiene program management, and EH&S auditing of research, manufacturing and contract manufacturing facilities.
Dean has spoken for a number of professional organizations including the U.S. Environment Protection Agency, the Colorado Safety Association, the Bay Area Environmental Safety Group, the National Association for Environmental Management, the National Safety Council, the Occupational Safety and Health Administration, and the American Industrial Hygiene Association.

Dean has also presented at the HPAPI 2012 and 2013 conferences in Philadelphia, PA, and at the High Potent Drugs 2013 conference in Mumbai, India.

Dean graduated with a B.Sc. degree in Engineering from the University of Wyoming and has dual master degrees in Environmental Policy and Management, and Technology Management from the University of Denver. He is a member of AIHA, ASSE, and NAEM.

Dean can be followed on Twitter: @affygility

Affygility Solutions

Since 2002, Affygility Solutions has provided environmental, health and safety services to the biotechnology, pharmaceutical, and medical device industry. Our services include the Affytrac EHS management tool, online training seminars, potent compound safety and categorization, occupational exposure limits, toxicology services and more. We've provided these services to small, mid-size and large companies throughout the United States, Canada and Europe. All of the environmental, health, and safety professionals at Affygility Solutions have many years of professional and hands-on life science industry experience.

Affygility Solutions is located in Broomfield, Colorado, just 30 minutes from Denver International Airport.

Workshop programme

8:30 Registration

9:00 Opening Remarks

9:10 Session 1 - Regulatory Basis for ADEs/PDEs and Preventing Cross-Contamination

Dean Calhoun

Dean Calhoun, President / CEO, Affygility Solutions
View Bio

Discusses the regulatory requirements in both the U.S. and E.U.

9:50 Session 2 – Determination of ADEs and PDEs

Dean Calhoun

Dean Calhoun, President / CEO, Affygility Solutions
View Bio

Discusses the how ADEs and PDEs are determined, and common mistakes

10:30 Morning Coffee

11:00 Session 3 – Basic Elements of a Cross-contamination Risk Assessment

Dean Calhoun

Dean Calhoun, President / CEO, Affygility Solutions
View Bio

Reviews the elements of a risk assessment including risk identification, risk analysis, risk evaluation, and risk reduction.

11:40 Session 4 – Ten misconceptions regarding OELs/ADEs/PDEs

Dean Calhoun

Dean Calhoun, President / CEO, Affygility Solutions
View Bio

Discusses the ten most common misconceptions regarding OELs/ADEs/PDEs

12:20 Closing Remarks

12:30 Close of Workshop

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VENUE

Holiday Inn London - Kensington

Wrights Lane, Kensington, London, W8 5SP, United Kingdom

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Holiday Inn London - Kensington

Wrights Lane
Kensington
London
United Kingdom

Holiday Inn London - Kensington

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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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