5 October 2021 Seminars

9:30 am - 10:30 am

Good Distribution Practice And How The ECA/PQG Monographs Can Help You’

Speaker

  • View full profile for Phil ButsonPhil Butson Director, R&D Quality Futures - Glaxo SmithKline
9:30 am - 10:00 am

Increasing Product and Process Understanding to Deliver Quality

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9:30 am - 9:50 am

Industrial Cyber Security for Pharma Engineers

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9:30 am - 9:45 am

Isolator Technology in Cell and Gene Therapy Processing

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9:30 am - 9:50 am

Tackling Drug Shortages Across Global Pharma Supply Chains

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9:50 am - 10:10 am

Supply Chain Risk Management

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9:50 am - 10:10 am

The Flexible Scope of LIMS in Today’s Pharmaceutical Operation

Integrating multiple sources of data from ERP, instruments and other systems to drive quality across the organisation is becoming ever more important. Whether you are a contract research organization, a contract manufacturer or a vertically integrated pharmaceutical company gathering, manipulating and disseminating data is central to your operation. Moving the ‘Internet of Things’ and the concepts of Industry 4.0 and Laboratory 4.0 from marketing hype to reality means that successful Laboratory Management Information Systems (LIMS) solutions need to be highly flexible. In this presentation we will discuss the continued importance of LIMS in today’s laboratory and show how LIMS fits within your laboratory informatics environment, no matter what that looks like. Of value to all pharmaceutical professionals (CxO, QA/QC, Laboratory) this presentation provides an insight into how LIMS continues to evolve as the glue that links the disparate elements of pharmaceutical manufacturing data and information together to ensure the safe release of final products in the pharmaceutical industry.

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9:55 am - 10:10 am

A Lean Approach to Raw Materials Identification

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10:00 am - 10:30 am

Applying Advanced Concepts to Formulation Design

The pharmaceutical oral products which are being generated now are more complex than the small white immediate release tablets that have been historically created.  Present-day drugs are a lot more complex and demanding, both in terms of their physicochemical properties and in terms of their biopharmaceutical requirements.   This presentation will show how data can be readily generated to optimise oral solid dose formulation design.

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10:10 am - 10:30 am

Chip Thinking for More Effective Pharma Plant Projects

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10:10 am - 10:30 am

Taking a New Client out of MHRA CMT Measures

10:20 am - 10:35 am

Guaranteeing Data Security & Accessibility

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10:30 am - 11:30 am

Break

10:45 am - 11:00 am

How to Effectively Cool Your Pharmaceutical Warehouse/Facility in a More Sustainable Way

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10:50 am - 11:30 am

Break

11:30 am - 11:50 am

Development At The Interface of Engineering And Molecules

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11:30 am - 11:50 am

GMP and GDP Training:  The Big Challenge – Demonstrating That Learning Has Taken Place

11:30 am - 11:50 am

Soft Skills and Critical Thinking

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11:30 am - 11:50 am

Sustainability in Pharmaceuticals – Learning From Other Industries

As the challenge to support an increasing population becomes more and more evident across the globe, sustainability is increasingly important. One of the most important tasks of our time is to produce high-quality and safe products while saving resources and ensuring quality of life. We (BASF) play an important role in solving these tasks. And our industry is capable of and has the responsibility to make a relevant contribution.

This presentation will discuss sustainability in the context of the chemical industry and look at how this may be applicable to pharmaceutical manufacture.

11:30 am - 11:50 am

Viewing Health By-Products As Resources Rather Than Waste

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11:30 am - 11:50 am

Vinyl-free Blister Solution, Designed to be Fully Recyclable

Investing in better is what drives us. Imagine a vinyl-free blister which is designed to be fully recyclable and compatible on all standard equipment, serving optimal performance in health protection and environmental safety.

Speaker

  • View full profile for Paul PeachPaul Peach Account Manager UK & Ireland - Klöckner Pentaplast
11:35 am - 11:50 am

Digital Tools for Pharma

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11:50 am - 12:10 pm

Magnetic Electrospun Micro-fibre Scaffold Assemblies: Examples of Their Use for 3-Dimensional Cell-Based Screening Applications

After gaining his Ph.D. from Edinburgh University in 1990, Gary joined Hoffmann La Roche (USA) to investigate retinoid pharmacology and the role of nuclear hormone receptors in foetal development. He then worked for GSK (UK) in 1995, gaining expertise in the development of cell-based assays within the CNS disease area as well as novel drug discovery assay technologies. Thereafter, Gary spent over 10 years at AstraZeneca (UK), developing novel cell-culture robotics and evaluating and implementing new assay technologies for respiratory and inflammatory diseases, before founding Aurelia Bioscience, a UK based Contract Research Organisation specialising in bioassay development and compound screening.

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11:50 am - 12:10 pm

Pharmaceutical Chemical Distribution in the New Normal

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  • View full profile for Thomas ArgentThomas Argent Pharmaceutical Business Manager - Brenntag UK & Ireland
11:50 am - 12:10 pm

Revised ICH Guidelines & Updates

11:50 am - 12:10 pm

The Quality Management System

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11:50 am - 12:10 pm

The Real Cost of Packaging

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12:00 pm - 12:15 pm

Driving QC Compliance and Efficiency with a LIMS

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  • View full profile for Tim DanielsTim Daniels Marketing Manager - Autoscribe Informatics
12:10 pm - 12:30 pm

Future UK Packaging Policy: Unpacked

The world today has a heightened focus on the impact that packaging waste has on our environment. This presentation will look at the current and approaching legislative landscape for packaging within the UK, including Extended Producer Responsibility, Plastic Tax and Deposit Return Schemes. We will cover what all this change means for UK businesses over the next few years, paying special attention to medical packaging.

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12:10 pm - 12:30 pm

Marketing Lifesciences; Successes and Learnings

 

 

12:10 pm - 12:30 pm

Product Owners: Fulfilling your Outsourcing Responsibilities

Safe, effective product, consistent with specification, must be our expectation.

Speaker

  • View full profile for Julie WalkerJulie Walker Principal Quality Consultant - JW Consulting Ltd
12:10 pm - 12:30 pm

The Cost of Quality (CoQ), or Rather The Cost of Poor Quality

12:10 pm - 12:30 pm

The Quality Management System

12:30 pm - 12:50 pm

From Batch to Continuous – New Opportunities for Supercritical CO2 Technology in (Bio)pharmaceutical Manufacturing

This presentation will provide an overview on existing methods for the production of pharmaceutical nanoparticles and show case studies on the production and control of the solid state form of APIs (e.g. polymorphs, cocrystals) using batch and continuous supercritical methods. A particular focus will be provided on a novel technology that uses nano spray drying as part of a continuous process for the production, isolation and downstream processing of nanoparticles. Examples will be provided on API nanomaterials produced which feature optimal rheological properties typical of large micron-sized particles, while still maintaining high dissolution rate profiles typical of nano-sized particles.

Speaker

  • View full profile for Dr Luis PadrelaDr Luis Padrela Lecturer/Principle Investigator - SSPC, Bernal Institute, University of Limerick
12:30 pm - 2:00 pm

Lunch

12:40 pm - 12:55 pm

Covering supply security for excipients today

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12:50 pm - 2:00 pm

Break

1:05 pm - 1:20 pm

GMP Compliance During and Post Pandemic

Speakers

1:30 pm - 1:45 pm

Non-Pulsating Super Metering Pumps for Continuous Flow Chemistry Applications

Speaker

2:00 pm - 3:00 pm

Advancing Next Generation Pharmaceutical Manufacturing by Collaborative Innovation

The Medicines Manufacturing Innovation Centre is a collaboration between CPI, University of Strathclyde (UoS), UKRI, Scottish Enterprise and founding industry partners, AstraZeneca and GSK. The centre’s purpose is to industrialise innovative technology and techniques in state-of the art, cGMP licenced facilities in collaboration with academia, healthcare providers industrial partners and regulators. The presentation will cover the facility design, Grand Challenges (current and future) and its digital strategy.

Speakers

2:00 pm - 2:30 pm

CCIT Method Selection through the Product Lifecycle

“Demonstrating CCI” for regulated package systems is best served by a “toolbox” approach incorporating multiple technologies, just as an analytical laboratory would have GCs, HPLCs, ICPs, etc, to characterize a drug product. Understanding the variables influencing method selection and implementation is crucial for regulatory success.

Speaker

2:00 pm - 2:30 pm

Clinical Trial Readiness – Getting the Most Out Of Your Clinical Trial

As you embark on your clinical development journey, there are a number of vital planning considerations to be addressed that will impact the success of your clinical trial, whatever your product. Join us to learn more about how to prepare so that your trial is set up for success.

Speaker

2:00 pm - 2:30 pm

Impact of Covid 19 Pandemic on Contract Manufacturing Organisations

The CMO sector has been severely impacted by Covid 19 pandemic and this has resulted in lasting changes to global supply chains. 

This presentation covers the wider implications for Pharmaceutical/Healthcare manufacturing and supply in the UK, now and in the future.  

Key topics: 

· Key supply challenges to manage during the pandemic in 2020

· Problems and opportunities created by the pandemic

· Case study learnings: GMP Manufacturing 

· CMO activities designed for the future  

· Technology Transfer, Data analysis and AI for contract manufacturing 

Speaker

  • View full profile for Giby GeorgeGiby George MD, Senior Consultant and QP - GMP Healthcare
2:00 pm - 3:00 pm

Welsh Pharma Showcase

2:15 pm - 2:30 pm

Why the Responsible Person Needs Training

2:30 pm - 3:00 pm

Artwork Related Recalls & Defects in the UK in 2020. How to Prevent Them!

A staggering one in three of all MHRA listed medicine defects/recalls are based on artwork errors.
During this presentation, there will be an overview of the types of errors and a brief exploration on how to prevent these by applying GMP principles appropriate to artwork origination.

2:40 pm - 2:55 pm

In-line process refractometer for Development and Production of an Active Pharmaceutical Ingredient (API)

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2:50 pm - 3:45 pm

Break

2:50 pm - 3:45 pm

Break

3:00 pm - 3:45 pm

Break

3:00 pm - 3:45 pm

Break

3:45 pm - 4:15 pm

Pharma 4.0

Nick plans to bring a short update on the Pharma 4.0 SIG team discussions, development of operating models and guidelines as well as some practical opportunities for us to start developing our future facilities and the traditionalist potential barriers to progress.

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  • View full profile for Nick KestertonNick Kesterton Head of Automation, Control and Instrumentation PM Group - PM Group
3:45 pm - 4:05 pm

The Impact of Annex 1 and How It Will Change Laboratory Practises

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3:45 pm - 4:15 pm

Using Film Coating Innovation to Support Product Development and Patient Adherence

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4:05 pm - 4:25 pm

Machine Learning applied to Pharmaceuticals

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4:05 pm - 4:25 pm

The Rise of the Machines

With an ever-increasing competitor market for the production of tablet based pharmaceuticals, businesses are looking to find improvements in productivity. In this presentation we will explore how improvements can be made through washing automation which is now becoming a critical aspect within manufacturing processes. The presentation will focus on the transition from the historical methods of manual cleaning and decontamination of Change Control Parts to semi and fully Automated solutions. We will also review a typical high production installation that relies completely on manual washing capabilities and uncover all the benefits which can be gained from making steps towards a truly controlled and automated washing solution.

Speaker

  • View full profile for Richard ClarkeRichard Clarke Business Development Manager - IWT Cleaning Excellence
4:15 pm - 4:35 pm

Managing Millennials

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4:15 pm - 4:45 pm

On the Processibility and Manufacturability of Pharmaceutical Solids

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  • View full profile for Dr Ali HassanpourDr Ali Hassanpour Associate Professor, School of Chemical Process Engineering - University of Leeds
4:25 pm - 4:45 pm

Effect of Proper Pressure Safety Device Selection

Overpressure protection on bioprocessing and pharmaceutical equipment needs to be considered to protect life and investments. In cases where unacceptable pressure levels can be reached safe and reliable pressure protection devices are required. Regulatory standards such as EN13311 specify the requirements for general biotechnology equipment whilst some specific processing equipment is listed with recommended solutions.
One of the often-underestimated health risks is related to the unintended leakage of pressure relief devices such as conventional pressure relief valves, leading to either ingress of microorganisms affecting the quality of processed media or exposure of public or workers to potentially hazardous media. Choosing a suitable leak-tight pressure relief solution such as bespoke rupture or bursting disc devices can mitigate such risks whilst avoiding potential cross contaminations between individual production batches by their smooth and cleanable surface configuration.

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4:25 pm - 4:45 pm

Use of Qualitative Process Understanding Tools in Pharmaceutical Development and Manufacturing

Qualitative process understanding tools can help with many aspects of process design, scale-up, technology transfer and manufacturing. This talk describes some of the applications in pharma and some recent developments arising from collaborative projects.

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4:35 pm - 4:50 pm

Pharma Distribution and how it’s Evolved

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