The Exhibition Making Pharmaceuticals
Transcript of The Exhibition Making Pharmaceuticals
Making Pharmaceuticals
Supported by:
National Conference Centre, Birmingham
26-27 April 2016
Exhibition & Conference
Register now at www.making-pharma.com@makingpharma
FREE to Attend
Research to Finished Product70+ Seminars & Workshops
90+ Exhibitors
A.J. Tyzack & Co.Adelphi Healthcare PackagingAlexanderwerkAllied Pharma ALMAC ALS (UK) LLP Amphenol Advanced Sensors
GermanyAntech UK & IrelandAPP ElectronicsAsh ScientificAstech IT Solutions Azbil Telstar UK Azelis UK Life SciencesAZO LIquidsBecton Dickinson UKBiogrundBosch Packaging TechnologyBritish Contract Manufacturers
and Packers AssociationBroughton SoftwareButterworth Laboratories Caleva Process SolutionsCIMLOGICClarity Compliance SolutionsCustom PharmaceuticalsDaraDec UK EcolabEdwards AnalyticalEMS Particle Solutions UKEXCiPACTExtract TechnologyFitzpatrick
Fleet LaboratoriesFormpipeFrewittGB Festo UKGEAGerteisInnopharma LabsInternational Society for
Pharmaceutical EngineeringInternational Laboratory ServicesInstitution of Mechanical EngineersIPEC EuropeKAYEKG PharmaKerry IngredientsLabocontroleLabtexLake Life SciencesLa Tene MapsLGCLovibond TintometerManufacturing ChemistMG2Molins TechnologiesMüllerNetzsch Mastermix NotterO’Hara TechnologiesOrigin PackagingOrthos EngineeringPackaging Coordinators Inc.PAP ServicesPharmaterialsPharma Machinery
PharmigPiNKPorvair Filtration Group PPMAProCepTQCLQuadro EngineeringQuality ContextReading Scientific ServicesRiva EuropeS3 ProcessSEPPIC Air Liquide Healthcare
Speciality IngredientsShin Etsu Pharma & Food Materials
DistributionSmithers Pira and Smithers Rapra Staubli (UK) Connectors DivisionStaubli (UK) Robotics DivisionSurfachemSTERIS CorporationSynergy HealthTeknomek Trinity ScientificThe Institute of Clinical ResearchUbichemVaisala OyjVeolia Water TechnologiesVMIWheaton UK Wickham LaboratoriesYgrosYtron-Quadro (UK)Ytron Process Technology
The ExhibitionThe UK Pharmaceutical market is ripe for growth; it’s a great time to be part of the industry, but your strategy needs to be right. Making Pharmaceuticals can help.Please visit the web site to register, to qualify for benefits, and for everything else you need to know.
Just some of this year’s exhibitors
For the latest programme and to register online, visit www.makingpharma.com
Source Manufacture Outsource
Making Pharmaceuticals is designed to help industry improve manufacturing processes, address product formulation / reformulation, reduce undesired variability, deliver consistent product quality, improve process robustness and enhance efficiency.
Research to Finished Product
Making Pharmaceuticals is the only event in the UK dedicated to the detailed and complex issues associated with testing, sourcing, manufacturing, outsourcing and delivering consistent products to the pharmaceutical market.
During the 2-day period of Making Pharmaceuticals, visitors are able to attend a series of seminars compiled by a number of leading authorities in the UK.
Making Pharmaceuticals, is designed to bring together everyone involved in the product development life cycle, leading to commercial manufacturing of pharmaceuticals, and provides an essential focus for the many different skills, and range of expertise necessary to deliver consistent products.
Making Pharmaceuticals provides a forum that will help attendees to solve current challenges, and to prepare for the ones to come.
IdeasInformationAnswers
The attendee profile includes:• Chemists & Formulators• Consultants• Engineers / Engineering• Importers• Management• Marketing & Business Development• Microbiologists• QA/QC• Qualified Persons• Production• Process Development• Regulatory• Validation Disciplines
FREE There is no fee to attend the
exhibition, seminars or workshops
Programme sponsored by:
Media Partners:
Butterworth is a UK based contract laboratory supporting the global pharmaceutical industry. Specialising in the quality control analysis of excipients, API, drug product, packaging and medical devices using recognised international standards, we also develop and validate methods to be used for quality control purposes using a wide range of techniques.
2016 features a focus upon Ingredients and Ingredient suppliers to the Pharmaceutical industry:-
• Two full days of dedicated ingredient conference content
• Sessions presented by key supporting organisations; IPEC Europe and EXCiPACT
Exhibitor presentations:• Azelis• Biogrund• Shin Etsu• Kerry Ingredients• SEPPIC• ALMAC• RSSL
(EPI) Excipients and Pharmaceutical Ingredients at Making Pharmaceuticals
Register in Advancewww.makingpharma.com
Programme sponsored by:
26 April REGULATORY09.15 Regulatory Snakes & Ladders - Navigating Pitfalls of
Pharmaceutical Development Matthew Burton, Jenson R+ Limited
09.35 European Falsified Medicines Directive – Securing the Supply Chain Paul Martin, Aegate
09.55 New Product - Compliance Future Proofing David Thomas, Clarity Compliance
CLINICAL TESTING11.30 The Big Bang Theory: Combining Earned Value, Agile
Project Management and Principle Agent Theory for Clinical Trials Roger Joby, ICR
11.50 What’s Changing with ICH-GCP Dr Alison Messom, ICR
12.10 The Clinical Trial Regulation in a Nutshell Mark Richardson, ICR
DATA MANAGEMENT14.00 An Introduction to the GxP Cloud: Risks, Regulatory
Considerations and Vendor Assessment Keith Williams, Formpipe
14.20 The Path to Predictability in Life Science Supply Chains Sean Robinson, Astec IT Solutions
14.40 OEE /SPC with Operational Excellence Garry Smith, CIMLogic
WORKSHOP15.45 Cross-Industry Innovation for Pharma and Healthcare
iFormulate, Dr Jim Bullock, Dr Malcom McKechnie, Dr David Calvert
26 April INGREDIENTS / EXCIPIENTS09.15 How the EXCiPACT Certification Scheme Helps You
Comply with the Ascertaining GMP for Excipients Guidelines EXiPACT
09.35 How the EXCiPACT™ Certification Scheme is Helping Excipient Suppliers With the Increasing Demands for Audits: - the Suppliers’ View EXiPACT
09.55 How the EXCiPACT™ Certification Scheme is Helping Excipient Suppliers With the Increasing Demands for Audits: - the Users’ View EXiPACT
12.00 Aqueous Ready-To-Use Film Coating Formulation Based on HPMC-AS Dr Mahmud Yunis, Biogrund
14.00 Novel Excipients from Kerry for Product Development Szilard Borbely, Kerry Ingredients
14.20 Skin Feel Modification for Topical Formulations Richard Summers, Azelis
14.40 Applications Using a Multi Functional Excipient, L-HPC Shilpa Mistry, Shin Etsu
15.45 Dermopharmacy Kathleen Allain, SEPPIC
27 April INGREDIENTS / EXCIPIENTS09.15 EU GMP Risk Assessment for Excipients
Kevin Hughes, Colorcon Limited09.35 Implementation of ICH Q3D
Andrew Teasdale, AstraZeneca09.55 FDA Inactive Ingredient Database
Liz Meehan, AstraZeneca
11.30 Characterisation of Pharmaceutical Powders from the Nanoscale to the Macroscale Ross Blezard, Reading Scientific Services Ltd (RSSL)
11.50 Crystallisation of Pharmaceutical Compounds - The Chemists’ Role in Protecting Intellectual Property Aeri Park, Almac
12.10 Film - Coating Kathleen Allain, SEPPIC14.00 Solid Dispersion Using Cellulose Derivatives
Shilpa Mistry, Shin Etsu 14.20 Utilising Excipient Technologies for Greater Patient
Benefits Enosh Mwesigwa, Azelis
26 April MICROBIOLOGY AND PHARMA09.15 Factors to Consider When Designing a Disinfectant
Efficacy Test Rachel Blount, Ecolab Contamination Control
09.45 Microbiological Aspects of Risk Assessment in the Plant Andy Martin, ABM Consulting Ltd
11.30 An Approach tp Process Development pf PMDI’s Using Cold Fill and Pressure Fill Technology Steve Haswell, 3M UK PLC
11.50 Manufacturing Risk Identification in Facilities Shared for Different Products: a Toxicologist’s Viewpoint Chris Collins, Q Scientific Consulting Ltd
12.10 Closures Advantaged Technology, Managing Closures on the Filling Line Process Stepano Beni, Cristina Testoni, Allied Pharma
14.00 Sterile Process Connections Craig Forrester, Staubli (UK) Limited
14.30 True Cost of Water Kalpesh Shah, Veolia Water Technologies
15.45 Serialisation Grainne Hughes, ALMAC16.05 Early Access to Innovative New Medicines
– A Continually Evolving Environment Mark Corbett, Consultant
16.25 Update on Annex 16; Certification by QP and Batch Release Mukesh Patel, CommQP Pharmaceuticals Services Ltd
27 April PHARMACEUTICAL ENGINEERING09.15 Data Integrity – The Current Regulatory Position
and GAMP® Perspective Chris Clark, Ten Ten Ten Consultancy
11.30 The Use of ISPE Base Guidelines in Achieving Cost Effective GMP Compliance Rob Walker, ISPE
PACKAGING14.00 Innovative Ways to Ensure Safety for Children and
Provide Senior-Friendly Solutions Stephen Wilkins, CEO, Child-Safe Packaging Group
14.20 Putting the Patient First - Patient-Friendly Packaging Phill Marley, Packaging Intelligence Manager, AstraZeneca
15.00 The Latest Developments, Technologies and Strategies in Anti-Counterfeit and Tamper-Resistant Packaging Andrew Love, VP Capability Development, Be4ward Ltd
15.20 Developing Your Serialisation Strategy – Key Learnings Andy Cumming, Managing Consultant Be4ward Ltd
26 April OPERATIONAL EXCELLENCE09.15 The Supply Chain and the Impact of Operational
Excellence Claire Edwards, GSK09.35 Operational Readiness Leading to Excellence
Adrian Mills, Strategic Projects and Engineering Solutions Limited
09.55 Effective Equipment Reliability in FMCG Marcus Valance, Alicia Sanchez Espin, GSK
11.30 Contamination Control Chris Hurst, GSK11.50 Avoidance of Physical Contamination
David McFarland, GSK12.10 Contamination Control TBA
PROCESSING14.00 Front End FactoryTBA14.20 The Serialisation Solution - What Does it Offer to
Continuous Processing?TBA14.40 Continuous Processing and Related DisciplinesTBA
QUALITY CONSIDERATIONS15.45 Avoid Deviations TBA16.05 The Importance of Containment Ian Skinner, Skinner
Associates Ltd16.25 Human Factors
Karen Stevenson, GSK
27 April NEW TECHNOLOGIES09.15 Innovation in Processing Darren Ragheb, Centre for
Process Innovation 09.35 Granule Size Distribution of Roller Compaction Process
Riyadh Al Alsady, Sheffield University09.55 Development and Implementation of In Vitro Methods
Wickham Laboratories11.30 Process Microfiltration in the Pharmaceutical Industry;
Processes, Validation and Economics Porvair Fitration Group
12.00 Binary Ionization Technology Simon Bailey, Azbil Telstar UK
BIOSIMILARS14.00 Are too Many Cooks Spoiling the Biosimilars Broth in
the UK? Dr Duncan Emerton, BioSimilarz
Room A Room B Room C Room DMaking Pharmaceuticals Seminar Programme
Register in Advance www.makingpharma.com
OPERATIONAL EXCELLENCE11.30 Operational Excellence: A Source of Competitive
Advantage? Dr Patrick McLaughlin, Cranfield University
11.50 Operational Excellence: Implications and Opportunities Dr Phil Warner, Cranfield University
12.10 Operational Excellence: Facing the Future Dr Nicola White, Cranfield University
14.00 Improved Process Understanding of Fluid Bed Granulation and Coating using Current PAT Solutions Luke Kiernan, Innopharmalabs
14.20 Automated Washing Principles and Common Mistakes Oliver Van Houtte, Steris
PHARMACEUTICAL QUALITY15.00 Supply Chain Risk Management – The Weakest Link
Steve Moss, Supply Chain, Pharmaceutical Quality Group15.20 Latest Developments in Packaging Materials GMP
Standard – PS 9000 David Abraham, Pharmaceutical Quality Group
15.40 Focus for Pharma Industry – Data Integrity Esme Gibb, Pharmaceutical Quality Group
27 April09.15 Metals Analytical Techniques for Pharmacopoeial
Compliance Reading Scientific Services Ltd (RSSL), Alan Cross
09.35 The Importance of Colour Measurement for the Pharmaceutical Industry Lovibond Tintometer, Elizabeth Wilkinson
09.55 Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD Frank Judge, Butterworth Laboratories Ltd
Programme sponsored by: