26 April 2023 Seminars
How to Effectively Manage a Remediation Programme
- Giby George MD, Senior Consultant and QP - GMP Healthcare
IPEC Excipient Information Package and the New Sustainability Chapter
- Geertrui Haest Cargill and IPEC Europe
Safety Considerations in Manufacturing Pharmaceuticals
- Claire Edwards Haleon
Screening of Pharmaceutical Polymorphs
Polymorph expert Ruwanthi Gurusinghe will talk Custom Pharma Services' approach to the screening of Pharamceutical Polymorphs.
More than 50% of commercially available drug candidates have more than one polymorphic form. Each morph may show differences in their physicochemical properties such as dissolution rate, bioavailability, physical and chemical stability. Various mechanical and environmental factors may cause unintentional transformations between different polymorphs. The presentation will cover:
An overview to the polymorphism.
- Factors which affect polymorphic transformations.
- The impact of polymorphic transformations in pharmaceutical compounds.
- The importance of identifying the ideal polymorphic phases of drug compounds.
- Polymorph screening techniques including X-ray crystallography, thermal methods, spectroscopic and microscopic.
- Dr Ruwanthi Gurusinghe Formulation Scientist - Custom Pharma Services
Workshop: Helping to Secure the Pharmaceutical Excipient Supply Chain
Back in 1998, the World Health Organisation (WHO) stated that there were more than 500 deaths worldwide in the previous 60 years caused by use of falsified excipients. Since then, even very recently, further examples have occurred within the supply chain with dramatic impact caused for example by criminal activity, contamination, mislabelling, or upgrading of industrial grade material manufactured under non-GMP conditions.
As a result, the supply chain of pharmaceutical starting materials, in this case excipients, has been identified by regulators and industry as an important part of medicinal product safety. In a globalised world, excipients are supplied across continents and handled by an increasing
number of different parties. The increasing complexity of the global supply chain brings with it an increased risk in excipient security.
This workshop will seek to show how all parties within the supply chain can be supported (e.g. pharmaceutical excipient manufacturers, distributors, traders, brokers, re-packers,
carriers, warehouse providers) and detail some tools which are available to ensure supply chain security and support global drug safety.
Hear from experts on what’s required to adequately secure the storage and distribution of excipients and join in the discussion as to how this can be demonstrated to the satisfaction of all parties involved. The session has these key objectives:
- To understand that as far as pharmaceutical excipients are concerned, concerns around supply chain security have not gone away.
- There should be controls in place at each interface to ensure excipient security
upstream as well as downstream within the supply chain.
- With increasing complex supply chains, there are tools including third party certification schemes to complement your knowledge of supply chain pedigrees.
Having registered to attend Making Pharmaceuticals, or Distributing Pharmaceuticals, register your place on the workshop HERE
Pharmaceutical Supplier Qualification
- Richard Coe GDP Responsible Person - Protogen Consulting
Raman Imaging – Not Just a Powerful Research Technique But Also a Fully Validated QC Tool
- Dr Adam Holland Senior Product Manager, Raman and micro-PL spectroscopy - HORIBA
The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
- Andrew Teasdale AstraZeneca and IPEC Europe
Raman Spectroscopy Solutions for In Line and Off Line Monitoring
From raw material qualification, in-process monitoring to finished product analysis, Raman Spectroscopy offers time and cost savings for process and bioprocess quality control. Discover how you can optimize your bioprocess workflows with handheld and portable Raman analysers.
- Gina Suarez Channel Manager - Thermo Fisher
A-TEEM (Absorbance – Transmission Excitation Emission Matrix) – the Future of PAT and QC/QA in Biopharmaceutical Production
- Dr Giorgia Marucci Regional Product Manager - Fluorescence Spectroscopy - HORIBA
Engineers’ Role in Managing Third Party Engineering Service Contracts
- Zhiru Tang Platforms Engineering Manager - GSK
Rapid Approval for Parallel Import Submissions
- David Guest Ex-MHRA Part-Time, Independent Consultant - Parallel Import Licencing
GDP- Building and Maintaining an Effective QMS
- Neil Wayman Secretary - PQG
Operational Excellence in Contract Manufacturing
- Niall O’Brien Consultant - GMP Healthcare
Break & Exhibition
Electronic Work Instructions – A Use Case for Digitalisation Technology
- Tony Margetts IChemE
Break & Exhibition
Break & Exhibition
Lite MES – A Case Study for Agile Digital Manufacturing
- Neil Wetherall Managing Director - Factorytalk Limited
Break & Exhibition
Workshop: The Future of the Pharma Industry and What it Will Take to Succeed
In 2022 a new word just entered the Collins English Dictionary. ‘Permacrisis – an extended period of instability and insecurity’. This will present unique challenges and opportunities to everyone in the Pharma Industry. Important questions must be answered:
- How will companies cut costs (by 30% +) and maintain compliance?
- How will you turn ‘disruptions’ into business advantage?
- What must you stop doing, start doing and do better?
- How will you attract, retain, and develop the best talent?
- How can you educate your team – without a budget?
- How can leaders make the right decisions despite the pressure, stress, and high levels of uncertainty?
This will be a PowerPoint free zone! To achieve deep learning and personal development the session will be highly interactive and involve group work and problem solving. The session has three key objectives:
- To examine the challenges you face and to answer all your questions
- To summarize what it will take to thrive in a Permacrisis
- To have fun and leave the session buzzing with new thoughts, ideas, and solutions
Session Duration: 2.5 hours
This workshop must be pre-booked, and by individuals who have already registered to attend Making Pharmaceuticals or Distributing Pharmaceuticals. Applicants will be notified 2 weeks before the event whether they have a place on the workshop.
Please book your place HERE
- Martin Lush Ex-VP - NSF International
Break & Exhibition
Break & Exhibition
Amorphous Solid Dispersion Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools
- Hetvi Triboandas PhD Student - De Montfort University
Applying for a Wholesale Distribution Authorisation (WDA(H))
Presentation looks at exploring the benefits and requirements of holding a pharmaceutical wholesale licence, giving an overview of basic requirements to get set up and maintaining a wholesale licence alongside other business activities.
Bio-decontamination Procedures According to the Latest ANNEX – Use of VHP Generators
- Luca Marchesi Managing Director - PURE+ LTD
Capsule to Tablet: Excipient Choices for a Flexible Formulation Strategy
- Dr Sandeep Kumar Formulation Development Manager - COLORCON
Innovative and Disruptive Cell Transportation and Storage of Medium Product
CellShip® is a novel and potentially disruptive cell transportation and storage medium developed through a highly successful three-year Knowledge Transfer Partnership (KTP) between Life Science Group (LSG) and Coventry University. The Knowledge Transfer Partnership (KTP) is a national programme, partly funded by Innovate UK, designed to help businesses improve their competitiveness and productivity through partnerships with universities.
The KTP between LSG and Coventry University was awarded the highest grade of “Outstanding” by the KTP Grading Panel for its achievement in meeting KTP’s Objectives.
CellShip® is a liquid buffer that allows for the transport of cells at ambient temperatures without the requirement for cryopreservation. This could allow for the shipment of hybridomas, primary cells and other cells between researchers at ambient temperatures while maintaining the integrity and effectiveness of the cells. This product could also be extremely disruptive for cell and gene therapy manufacturing, allowing cells to be delivered to the patient at ambient temperatures without apoptosis that occurs following freeze/thaw cycles. This would also mean that harmful cryoprotectants would not be required.
An important benefit to note is that the protocol requires minimal cell manipulation.
It also reduces the risk of contamination and improves efficiency within the laboratory. To date, Cellship® is validated for up to 120 h of transport/storage at ambient temperatures. It is a cost-effective, safe, novel, and viable alternative to the storage and transportation of cells using standard cryopreservation methods, a useful tool, not only for research purposes but potentially suitable for biomanufacturing and transportation of Advanced Therapy Medicinal Products (ATMPs).
- Abeer AL Hubaysh Research Scientist - Life Science Group (LSG)
The Qualification of Vehicles and Transport Route Validation
- Chris Martin Chris Martin, Director & Senior Consultant - Christa GDP Pharma Ltd
Using the Three Pillars of 3D Printing to Support Pharma Manufacturing
Regardless of technology, there are always considerations for any manufacturing process to get the best from it. This unique presentation, delivered by an internationally recognised 3D print expert with 20 years of experience in 3D printing describes how transformative the power of 3D printing can be when applied correctly and how these same principles are already being adopted by the pharmaceutical industry to drive profitability, productivity, and business risk reduction.
- Tom Fripp Addition Design
An Introduction to Particle Size Analysis Basics for Pharmaceutical Ingredients and Formulations
- Dr Mauro Cappelluti Product Manager Particle Characterisation - HORIBA UK Ltd
How to Achieve Sustainable GDP Compliance
- Mark King Associate Director, Quality (QP, RP, RPi) - JensonR+ Ltd
Screening and Scale-up Techniques for Pharmaceutical Multi-Component Crystalline Drugs
- Dr Steven Ross Senior Formulation Scientist - Custom Pharma Services
Trends in Microbial Monitoring of Air in Aseptic Manufacturing
Assuring successful aseptic manufacturing of sterile requires an understanding of the difficulties and limitations of test methods employed.
Various current methods are discussed as to their strengths and weaknesses.
- John Cobb GMP Microbiologist - PMT (GB) Ltd
Partnership in Pharmaceutical Industry Post Covid: Collaboration and Competition Relationship
Covid 19 pandemic changed the dynamics of pharmaceutical companies and how they operate. It facilitated the research-based alliances and changed the perception toward partnership in the industry. The need for collaboration between competitors obligated companies to maintain the balance between collaboration and competition. The distribution of new molecules in different countries and region requires new levels of engagement, mainly in emerging economies. Pharmaceutical companies are seeking to conduct partnership with local partners in different regions to minimise the cost of distribution. The partnership between companies can be assessed to create many opportunities for competitive learning between partners.
- Dr Radi Haloub Associate Professor: Biotech and Pharmaceutical Management - University College London - UCL
Effective Training in the Pharmaceutical Industry
An overview of the regulatory requirements for training. GMP and GDP expectations with regards to training. How these requirements can be achieved in practice. Evaluation of an individual’s training needs – what they know already and what they need to be trained in. How to evaluate training and its effectiveness. Different learning styles and catering for these in training sessions.
- Dominic Parry Director - Inspired Pharma Training
Emerging Technologies for Making Pharmaceuticals at the Point of Care
- Dr Dennis Doroumis Professor in Pharmaceutical Technology and Process Engineering - University of Greenwich
Understanding Regulations – Examining the Impact of the Biocidal Products Regulation (BPR) on Automated Airborne Disinfection Systems and Their Use in Aseptic Processing Facilities
- John Chewins Scientific and Regulatory Director - Ecolab