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This Masterclass on Containment provides all relevant information in terms of how to produce highly potent or highly hazardous pharmaceutical products. The audience will understand where the OEL and PDE comes from and what is important to consider of the new EMA Guideline of setting health based exposure limits.

A case study on a risk assessment will provide the audience with a tool for performing risk assessment themselves. Technical Containment Solutions, together with their performance on the OSD or API Process Equipment, will provide the audience with an overview of what is on the market with detailed technical information. A case study on Containment based on the ISPE SMEPAC Good Practice Guide will round up the Masterclass.

During the Masterclass, the attendees will get the complete overview on Containment: How to start on a Containment Project, looking in detail at a Risk Assessment, learning about different Containment Technology Systems and getting feedback on their advantages and their limits.

Previous attendees included:

 

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; Syndivia; Takeda Pharmaceuticals; The University of Bath; Thomson Reuters; UCL; University College London; University Of Bath;

Masterclass LEADER

keynote-img

Richard Denk

Head Sales Containment, SKAN AG

Richard Denk has studied mechanical engineering and is working at the company SKAN AG, headquartered in Allschwil in the position sales containment. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual in September 2015. The Containment Manual does provide a full overview on Containment. Furthermore, Mr. Denk is author at Maas & Peither GMP Publishing on containment and hygienic design and one of the authors of the ISPE Oral Solid Dosage Baseline Guide. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

SKAN AG

SKAN, founded in 1968, is one of the pioneer companies in the field of cleanroom equipment, isolator design and Containment for the global pharmaceutical industry. Innovative products, customer-specific solutions and an efficient service organisation have led SKAN to become a global market leader and important partner for industry and research laboratories.

Masterclass programme

8:30 Registration & Coffee

9:00 Welcome and Introduction

9:15 Containment: New Requirements based on the EMA Guideline on setting health based exposure limits

  • Containment - What does it mean?
  • PDE Permitted Daily Exposure - What impact does it have?

     

     

  • Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    10:00 Risk Assessment

  • How to perform a Containment Risk Assessment based on a Case Study
  •  

     

    Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    10:45 Morning Coffee

    11:15 Containment Life Cycle

  • URS Containment User Requirement Specification
  • Installation
  • Maintenance

  •  

     

    Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    11:45 Technical Containment Solutions Part 1

  • Requirements on Process Containment in API and OSD Production
  • Technical Containment Solutions with their pro and contra and what is important to consider
  •  

     

    Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    12:30 Networking Lunch

    13:45 Technical Containment Solutions Part 2

  • Requirements on Process Containment in API and OSD Production
  • Technical Containment Solutions with their pro and contra and what is important to consider
  • Case Study on Containment for OSD and API

  •  

     

    Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    14:45 Work Hygienic Validation

  • Case Study on an Containment Installation according to the ISPE SMEPAC Good Practice Guide

     

     

  • Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    15:15 Afternoon Tea

    15:45 Cleaning and Hygienic Design

  • What has to be considered during hygienic design to have an optimised cleaning performance?
  • Where are the critical areas?

     

     

  • Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    16:15 Q&A Session

    Richard Denk

    Richard Denk, Head Sales Containment, SKAN AG
    View Bio

    Martin Glättli

    Martin Glättli, Sales Engineering Containment, SKAN AG
    View Bio

    16:30 Close of Masterclass

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    VENUE

    Venue To Be Confirmed

    London, United Kingdom

    Highly Potent Active Pharmaceutical Ingredients Conference

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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.

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