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Learn how to apply the updated ISO Cleanroom Standards and comply with EU Guidance as well as assess product risk through effective cleanroom monitoring. Additionally, learn about choice of monitoring equipment (specification etc.) and establishing risked based sample locations.

All current cleanroom standards and GMP guidance's recommend or require a risk based monitoring approach. Additionally, there is an increase in regulatory observations related to lack of risk based environmental monitoring. This workshop will address the requirements and provide guidance on how to establish a risk based Environmental Monitoring Program.

Multiple Case Studies will be utilized as examples related to deficient Environmental Monitoring Programs which have led to 483 observations, warning letters and data integrity issues.

Advanced Sterilization Products (J&J); Aequor Inc; Ajinomoto Althea Inc.; Allergan; Amgen; AntriaBio; B. Braun Medical Inc.; Battelle Memorial Institute; Baxter Healthcare Corporation; BGH International; Bimeda; Bimeda Inc.; Biomerieux; Cenexi; Charles River; Copan Diagnostics Inc; Excellent Pharma Consulting Inc; Genentech; Genentech Inc; Genentech, Inc.; Genzyme ; Global Drug Development Consulting; GSK; Janssen; JD Technologies, LLC; Microbiologics; Microrite; Millipore Sigma; Nipro PharmaPackaging; Pacira Pharmaceuticals Inc; PSC Biotech; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals Inc.; Renaissance Pharma; Sanofi Pasteur; Shire plc; STERIS Corporation; Steri-Tek; University of California San Diego; University of Salford;

Workshop LEADER

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Morgan Polen

Subject Matter Expert on Contamination Control, Microrite

Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

Microrite

Microite is a San Jose, CA based Consulting Company helping Pharmaceuticals, Biotechnology, Medical Devices, In-Vitro Diagnostics and Combination Products in the areas of Quality Assurance, Contamination Control, Microbiology, Process Development, Process Validation, Facility, Utility and Equipement Validation.

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Ziva Abraham

Ziva Abraham, Founder and CEO, Microrite
View Bio

Morgan  Polen

Morgan Polen, Subject Matter Expert on Contamination Control, Microrite
View Bio

9:10 Session 1: Case Study Review: LOearn from the mistakes of Others

9:50 Session 2: Understanding the changes to cleanroom standards (14644-1,2,3) and current regulatory thinking regarding GMP Annex 1; and discussion on recent 483 observations and waning letters

10:30 Morning Coffee

11:00 Session 3: Key Elements of Risk-Based Monitoring Program

11:40 Session 4: Group Exercise

12:20 Closing Remarks and End of Workshop

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Crowne Plaza San Diego - Mission Valley

2270 Hotel Circle North
San Diego 92108
USA

Crowne Plaza San Diego - Mission Valley

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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