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As the industry continues to see significant growth for drug products developed in prefilled syringe systems (PFS), there is a trend for pharmaceutical companies to evaluate more complex drug molecules, such as biologics.


The piston dimensions are critical to the function of the entire packaging system and help provide an increased level of confidence in the PFS system performance. By applying a 100% automated control on the piston dimensions, it allows for lower variability by minimizing the part-to-part changeability with consistent and predictable product performance and reliable machinability in fill-finish operations and maintaining proper container closure integrity.


Particles and dimensional defects in primary packaging can have significant impact on end-of-line rejects, reducing yield and patient safety. This next generation piston combines several critical quality attributes regarding tight particulate specification for visible and subvisible particulate specification and outstanding vision inspection allowing particle control on every single piston at 0.01mm².
Data will be shared on the key critical product requirements, such as performance studies in prefilled syringes, container closure integrity, dimensional measurement results and particulate measurements that can be used to support delivery system assessment and implementation at pharmaceutical companies.
 

Who Should Attend
• Quality Managers
• Heads of Quality
• Manufacturing/Operations Managers
• Heads of Manufacturing/Operations
• Heads of Fill-Finish
• Fill-Finish Manager
• R&D scientists
• Formulation scientists
• CMC regulatory
• Packaging engineers
• Engineers and Managers in Device Development and all other technical functions surrounding syringe systems
• Clinical and commercial Drug Product Manufacturing
• Formulation scientists
• Laboratory scientific staff and managers
• Parenteral manufacturing staff
• Sterility Quality Assurance
• Regulatory affairs scientists
• Pharmaceutical packaging component manufacturing staff
 

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FEATURED SPEAKERS

Christa Jansen-Otten

Christa Jansen-Otten

Director, Product Management, Prefilled Systems & Delivery West Pharmaceutical Services, Inc., West Pharmaceutical Services
Whitney Winters

Whitney Winters

Senior Director, Strategic Marketing and container Systems, West Pharmaceutical Services, Inc, West Pharmaceutical Services

Christa Jansen-Otten

Director, Product Management, Prefilled Systems & Delivery West Pharmaceutical Services, Inc., West Pharmaceutical Services
Christa Jansen-Otten

Christa joined West in 2005. In 2016 she was promoted to Director of Global Product Management, Prefilled Systems. During her time at West Christa has developed an expertise in prefillable systems and delivery technology in the technical customer service and marketing department.


Christa has worked within the pharmaceutical industry for more than 20 years and has gained experience as Quality Assurance Manager in one of the world’s leading pharmaceutical companies for sterile filling and packaging. In addition, she has spent several years with the leading prefillable syringe manufacturer in the customer quality assurance department.


Christa holds a Diploma in Biomedical Engineering from University of Aachen.
 

Whitney Winters

Senior Director, Strategic Marketing and container Systems, West Pharmaceutical Services, Inc, West Pharmaceutical Services
Whitney Winters

Whitney Winters joined West in 2007 as a pricing specialist where she worked with a variety of start-up biotech companies and large pharmaceutical customers in order to identify testing opportunities and coordinate completion of projects to meet customer needs. She has worked as an account manager, sales manager, and Senior Sales Director for emerging biologics where she led a team as they assist clinical phase biotech companies in North American and Europe with containment and delivery solutions. In her current role as Senior Director of Strategic Marketing she creates the strategy to drive promotion and adoption of high value programs, pharmaceutical device systems and custom product development. She has a passion for collaborating with customers to create new business opportunities and working internally to create innovative offerings for the life science market. She also helps to educate customers on the market trends for parenteral packaging as well as applicable guidances and FDA regulations.


Whitney received her MBA from Pennsylvania State University in 2011, and a B.A. with a specialization in chemistry from Northwestern University in 2002.
 

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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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