27 April 2022 Seminars

9:15 am - 9:45 am

Common GMP Deficiencies

Speakers

9:15 am - 9:35 am

Failures in the Temperature-Controlled Supply Chain – An Auditor’s Experiences

Speaker

  • Bob Hayes Vice-Chair, Pharmaceuticals Technical Activities Committee - Institution of Mechanical Engineers
9:15 am - 9:35 am

How to Approve EXCiPACT as a 3rd Part Audit Provider

Speaker

9:15 am - 9:20 am

Introduction to MTRC at ARU

Speaker

  • Prof. Selim Cellek Director of the Medical Technology Research Centre - Anglia Ruskin University
9:15 am - 9:35 am

Particle Size Analysis Basics For Pharmaceutical Ingredients and Formulations

Speaker

  • Andy Keating Sector Sales Manager - Life Sciences - HORIBA UK LTD
9:20 am - 9:40 am

Novel Therapies for Cataract

Speaker

  • Prof. Barbara Pierscionek Deputy Dean (Research and Innovation), Faculty of Health, Education, Medicine and Social Care - Anglia Ruskin University
9:35 am - 9:55 am

Application of EXCiPACT GMP to Excipient-like Materials Used in Pharmaceutical Drug Product Manufacture

Speaker

9:35 am - 9:55 am

Design for Successful Validation

Speaker

  • Bob Hayes Vice-Chair, Pharmaceuticals Technical Activities Committee - Institution of Mechanical Engineers
9:35 am - 9:55 am

Nutritional Solutions to Support Cancer Treatment

Speaker

  • Barbara Troesch Senior Scientific Affairs Manager Global Pharma Solutions & Clinical Nutrition - DSM Nutriitional Products
9:40 am - 10:00 am

Inhibiting DNA Repair in Human Cancer Cells

Speaker

  • Prof. Chris Parris Head of the School of Life Sciences in the Faculty of Science and Engineering - Anglia Ruskin University
9:45 am - 10:15 am

Common GDP Deficiencies

This session will be led by former MHRA GDP Inspectors and Operations Managers who will share some of the most common deficiencies and deviations from GDP requirements that are noted both on inspection and in the wider pharmaceutical wholesale industry.  They will highlight where potential compliance gaps can be found and suggest ways these can be mitigated.

Speakers

9:55 am - 10:15 am

Continuous Manufacturing of Pharmaceutical Nanoparticles (CM-NANO)

Speaker

  • Dr Luis Padrela Lecturer - Synthesis & Solid State Pharmaceutical Centre (SSPC), University of Limerick
9:55 am - 10:15 am

Managing Change – Control The Risk!

Speaker

9:55 am - 10:10 am

Regulatory Guidance on the Life Cycle Approach to Container Closure Integrity Testing

This presentation will look at the path of regulatory guidance over the last decade, in the context of container closure integrity inspection for pharmaceutical product packaging and help explain what this means across the manufacturing life-cycle.
We will cover why different approaches and justifications need to be considered for different stages of product development and manufacture and look at emerging technologies and where they fit across these various stages.

- Overview of regulatory guidance for CCIT
- interpretation of the guidance
- understanding the approach to choosing and justifying which method to apply to your product
- Overview of new technologies

Speaker

10:00 am - 10:50 am

Demonstration by Chemlink Specialties

Improving the palatability of oral dosage forms

Oral Disintegrating Tablets, Dispersible Tablets. Mini Tablets, Syrups, Liquids, Effervescent Tablets, Chewable Tablets, Sachets

Taste making and bitterness suppression are amongst the biggest challenges in the Pharmaceutical, Nutraceuticals and Veterinary markets today. If a medicine has an unpleasant taste then adults, children, and animals are reluctant in following through with dosages prescribed. In this demonstration we will be showing you how you can improve the palatability of your oral dosage form, and the simple ways in which you can easily improve the taste and the manufacturing process of oral dosage forms.

 

10:00 am - 10:20 am

Novel Nanomedicines for Cancer Therapy

Speaker

10:15 am - 11:30 am

Break

10:15 am - 11:30 am

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10:15 am - 11:15 am

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10:15 am - 11:30 am

Break

10:20 am - 10:40 am

Discovery of Novel Anti-fibrotic Drugs Through Phenotypic Screening

Speaker

  • Prof. Selim Cellek Director of the Medical Technology Research Centre - Anglia Ruskin University
10:20 am - 10:05 am

Leading Beyond Chemistry

We support customers along the entire product cycle from early development to commercial manufacturing.

Speaker

10:45 am - 11:30 am

Break

10:45 am - 11:00 am

Innovative Solutions for Clean and Sterile Processing

How can highly regulated producers of aseptic pharmaceuticals leverage flexible equipment solutions to achieve their regulatory, efficiency and manufacturing goals?

Speaker

11:10 am - 11:25 am

Equipment Innovation Supporting Annex 1 Changes

EU GMP Annex I set the rules for production of sterile products. The latest version points to additional focus on quality risk management, quality assurance and contamination control. The presentation will refer to equipment design and innovation in relation to aseptic filling, autoclave technology and inspection systems.

Speaker

11:30 am - 11:50 am

Compaction Simulators : A Material-sparing Method to Accelerate Tablet Formulation Development

Speaker

11:30 am - 11:50 am

E-PILs, What are They and What are the Opportunities to the Industry?

Speaker

11:30 am - 12:30 pm

Quality Risk Management in GDP

Speaker

  • Neil Wayman Secretary - Pharmaceutical Quality Group (PQG)
11:30 am - 12:00 pm

Surface Engineering Approaches to Control Biological – Surface Interactions

Speaker

  • Dr Paul Roach Reader in Biomaterials and Interface Science - Loughborough University
11:35 am - 11:50 am

Keeping it all in – Compendial and Supporting Techniques for Vial and Stopper Testing

In this presentation we will discuss the compendial requirements for vials and stoppers when used for vaccines, why these tests are carried out and practical issues.

Speaker

11:50 am - 12:10 pm

Artwork and Content Management; Feeding the e-PI Process and Delivering Exceptional Content Quality

Speaker

11:50 am - 12:10 pm

Overcoming the Challenges During Tableting

Speaker

  • Shilpa Mistry Head of Pharma,UK and Ireland - Chemlink Specialities
12:00 pm - 12:30 pm

Electrospinning: an Emerging Medicines Manufacturing Method

Speaker

12:00 pm - 12:30 pm

GAMP 5 and Data Integrity – Trends for Manufacturing Systems

In recent years there has been concern about the integrity of the data used to release pharmaceuticals from the manufacturing stage to the market. This presentation takes a look at the current guidance on how to identify threats to this data, and how to ensure the data is not compromised.

The presentation explains

  • ‘Data Integrity’,
  • What is meant by a computerised ‘Manufacturing System’,
  • the sorts of data being collected,
  • how to define what is critical,
  • the data lifecycle
  • the risks associated with the data,
  • how the risks are controlled

 

Speaker

  • Hilary Mills-Baker European Quality and Validation Manager - Emerson Automation Solutions
12:00 pm - 12:15 pm

H202 Decontamination: Understanding Cycle Efficacy with Enzyme Indicators

H202 decontamination can be a complex process due to the many variances that can effect cycle efficacy. Learn how Enzyme Indicators can provide a rapid insight into these variances in a faster, smarter and safer way.

Speaker

12:10 pm - 12:30 pm

Harnessing Raman Imaging to Boost Pharmaceutical Product Analysis, From Formulation to QC

Speaker

12:10 pm - 12:30 pm

The Art of the Possible

Speaker

12:30 pm - 2:00 pm

Break

12:30 pm - 2:00 pm

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12:30 pm - 2:00 pm

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12:30 pm - 2:00 pm

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12:30 pm - 2:00 pm

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12:50 pm - 1:05 pm

Formulating Effective Topical Solutions Using Silicone Excipients

Liveo healthcare silicones from Dupont come in a range of product forms which can be used in a wide variety of topical product formulations, for an equally wide range of functionalities - from enhancing delivery to aiding rub in characteristics and skin feel.

Speaker

1:00 pm - 1:50 pm

Demonstration by Protak Scientific

Protak Scientific Enzyme Indicators

Cycle efficacy testing with Enzyme Indicators, the faster, smarter & safer way

Join us as we demonstrate how Enzyme Indicators are used, tested and analysed to achieve a greater understanding of gaseous decontamination cycle efficacy than that of conventional methods that can be shown in minutes rather than days.

1:15 pm - 1:30 pm

Sustainable Protection for Pharmaceuticals

Klöckner Pentaplast introduces kpNext™: Recyclable blister films that are a plug & play solution.

Speaker

2:00 pm - 2:20 pm

Dessicants and Sustainability in Active Packaging

Speaker

2:00 pm - 2:20 pm

Excipient Sustainability : A User and Supplier’s Perspective

Speaker

2:00 pm - 2:20 pm

Remote Audits – What Can We Learn From The Past Two Years to Develop Successful Strategies for the Future? David Waddington, NSF Health Sciences

The pandemic has challenged industry and regulators to adopt innovative approaches to traditional methods of auditing to ensure safe and continued supply of essential medicines. For the past two years on site audits have been largely replaced by ‘desktop’ or virtual audits. Drawing from his experience of over 150 remote audits, Dave Waddington will look at possible scenarios for the future. Is the industry ready to truly embrace a risk-based approach to supply chain oversight? How can we use data and metrics to decide the allocation of resources most effectively for insightful audits? Are remote audits here to stay?

Speaker

2:00 pm - 2:20 pm

The Guide to GMP

The European Union's Guide to GMP. The legal status of GMP. How GMP is worded and structured. How GMP is regulated and inforced.

Speaker

2:00 pm - 2:20 pm

When Clean Means Corrosion

Speaker

2:20 pm - 2:40 pm

Best Practices Guide for the Safety Evaluation of “Novel” Pharmaceutical Excipients with Reference to the IPEC Safety Guide

Speaker

2:20 pm - 2:40 pm

Driving GDP Compliance for Outsourced Logistics Activities

Speaker

2:20 pm - 2:40 pm

Ratio Calibration Procedure for Enhanced Accuracy and Ease of Determination of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging

Speaker

  • Frank Judge Consultant Chemist - Butterworth Laboratories
2:20 pm - 2:40 pm

Smart Factory: Practical Examples

As part of our smart transformation program, we've been globally recognised by Gartner and the World Economic Forum for leading the way. Our presentation will share practical vendor agnostic examples of how you can do the same in your own operations, focusing on the main challenges identified in a smart transformation factory;
1. Identifying where to start
2. Scaling up digitisation
3. Maintaining uptime in a period of transformation
4. Empowering employees to ensure buy in

Speaker

  • Mark Yeeles VP Industrial Automation UK&I - Schneider Electric
2:40 pm - 3:00 pm

Data Integrity Maturity Assessments – Trends and Tools

Speaker

  • David Thompson Principal Consultant - Clarity Compliance Solutions Ltd
2:40 pm - 3:00 pm

Excipient Selection for Paediatric Medicines Using a Risk/Benefit Approach

Speaker

2:40 pm - 3:00 pm

Why the Future is Flexible in CDMOs

For pharmaceutical contract drug manufacturing operations (CDMOs), flexibility is key. An informed specification plays a big part in CDMOs being able to adapt to new projects. Using modular and bespoke furniture provides manufacturers with the ability to rapidly reconfigure their cleanrooms and production spaces to allow for each different contractual requirement.
The ability to maintain contamination control between projects is integral to this flexible approach.
This presentation looks at how, by thinking flexibly, you can specify adaptable and therefore cost effective furniture, whilst maintaining exemplary risk management and without compromising on hygiene standards.

Speaker

3:00 pm - 3:20 pm

Production as a Service in Pharmaceutical Environment

Manufacturing pharmaceuticals remains resource intensive and supply chains are increasingly affected by investment risks. To reply to this uncertainty while allowing manufacturers to access new machinery, performance oriented payment models are growing in relevance in the manufacturing world: As-a-service concepts enable manufacturers to pay for the outcome of the necessary production equipment, instead for the equipment itself. External investors own the assets and sell production output to one or multiple tenants. The foundation for these business models are IoT ready production lines. HAHN together with its partner FlexFactory are working on PoC for pharmaceutical manufacturing centered around advanced automation capabilities.

Speaker

3:20 pm - 4:00 pm

Break