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In recent years Mold Contaminations and Recalls have been a focus of attention for the FDA. The wave of mold related inspections and recalls are in response to a deadly fungal meningitis outbreak linked to contaminated steroids from a now infamous compounding pharmacy and a wave of high profile recalls. A risk-based approach to mold is required in order to prevent a catastrophic outcome
There is no one solution for preventing, controlling and remediating mold contaminations. The same mold may be detrimental in one product but may have no clinical implication in another.
Mold proliferation, prevention and control are not understood because there is a gap in mycological expertise within the pharmaceutical industry. SMi invites you to attend this never before offered intensive workshop.
 

All current cleanroom standards and GMP guidance’s recommend or require a risked 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.
 

Key Job Titles:

Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist

Global Presence:

Attendees from all over the world attend our events. Gain insight from representatives from the USA, UK and Europe.
 

Workshop programme

8:30 Registration & Coffee

9:00 Workshop leader introduction

9:10 Understanding Mold (Hands-On Exercise)

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

Understand mold classes, sporulation patterns and how easy to kill mold can switch its proliferation method where the spores are impossible to eradicate.

 

·         This will be a hands on exercise using fungal reference texts and images

·         This exercise will allow attendees to understand that no matter what method you use, you may not always have the correct identification.

·         Learn about the sources  and proliferation methods of various cleanroom mold isolates and develop a prevention plan

 

9:50 Mold Myths and Facts

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

• Myths about disinfection and disinfectant qualification related to mold removal
• Understanding the fungicidal activity of various disinfectants used in the industry, how fungicidal label claims are established and why they could be misleading
• Cleaning practices that actually encourage mold growth
 

10:30 Morning Coffee

11:00 Investigating Mold Contaminations

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

Often the risk of mold contamination is not addressed until contamination has happened!
• Understand why investigating and managing mold contamination can be difficult without proper knowledge of mold and controlled environments
• Points to consider when investigating mold contamination
• Why excessive cleaning and disinfection or fogging is not the solution when it comes to cleanroom contamination by mold
 

11:40 Clinical Relevance of Objectionable Mold

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.

Learn about what mold is objectionable via which mode of administration
• Guidelines on how to assess risk of mold in your product
• Understanding the level of risk and making changes to remediate the situation

 

12:20 Closing remarks

12:30 End of workshop

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VENUE

Battery Wharf Hotel

3 Battery Wharf, Boston, MA, USA

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Battery Wharf Hotel

3 Battery Wharf
Boston 02109
USA

Battery Wharf Hotel

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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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