27 April 2022 Seminars

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.

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

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.

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

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

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.

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.

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

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.

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.

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.

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

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?

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

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

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.

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.