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Recently, there has been a lot of interest associated with the potential use of synthetic (non-animal based) reagents for bacterial endotoxin testing. This workshop will provide an in-depth overview of the global perspective on the use of such reagents, including their regulatory status.

In the hands-on portion of the workshop, we will focus on executing a recombinant kinetic chromogenic assay, testing samples and detailed data interpretation with the primary focus on comparability of the data with conventional amoebocyte lysate- based assays.

This interactive workshop will provide the following:
- Overview of global status of recombinant reagents for BET
- Hands-on session – kinetic chromogenic testing
- Data interpretation
- Troubleshooting kinetic chromogenic assays
- Equivalency of the recombinant reagents to LAL reagents

• Senior Microbiologists
• Lead Scientists
• Laboratory Managers
• QA Specialists
• Drug Substance External Manufacturers
• QC Scientists
• Heads of Quality
• Business Development Managers
• Pharmaceutical Microbiology Consultants
• Higher Pharmacopoeial Scientists
• Analytical Standards Specialists

Workshop programme

All timings are in Eastern Daylight Time (EDT) – GMT-4

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

9:10 Overview of status of recombinant

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• Status with the US, European and Japanese Pharmacopeias
• Status with the Chinese Pharmacopeia

9:50 Hands-on portion: Kinetic Chromogenic Assays

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• Preparation of the test
• Software settings
• Executing the test

10:30 Coffee Break

11:00 Data Interpretation

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• Basic data interpretation
• Comparability with LAL-based data
• Troubleshooting general issues

11:40 Future outlook

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

• Overview of requirements for alternate testing

12:20 Closing Remarks

Veronika Wills

Veronika Wills, Manager, Technical Services, Associates of Cape Cod
View Bio

12:30 End of Workshop



Veronika Wills

Veronika Wills

Manager, Technical Services, Associates of Cape Cod

Veronika Wills

Manager, Technical Services, Associates of Cape Cod
Veronika Wills

Veronika has been working in the endotoxin industry for the past 12 years and currently manages the Technical Services department at Associates of Cape Cod, Inc. Veronika is a specialist on testing complex samples, method development, regulatory aspects of endotoxin testing, development and delivery of educational and technical contents. She attends and speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.


Online Virtual Event

Online Virtual Event

Online Virtual Event



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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.


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.


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.


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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