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Pharma conference aims to improve regulatory harmonization between the U.S. and Europe

19/09/2018 12:39:35
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ImagesClick Image for 300dpi jpg filePharma conference aims to improve regulatory harmonization between the U.S. and Europe

One of the key topics at the IFPAC Cortona Conference 2018 will be “Manufacturing Innovation and Global Regulatory Harmonization”. In relation to this subject, Optimal Industrial Technologies will discuss how to address regulatory compliance and cyber security issues when implementing process analytical technologies (PAT) in pharmaceutical manufacturing processes. During the talk, Optimal will also discuss how PAT knowledge management platforms such as synTQ provide powerful and reliable software tools to provide quality assurance, data tracking and traceability.

IFPAC is a global forum that brings together experts from academia, industry and regulatory bodies to discuss the latest trends and advances in PAT. Key topics include quality by design (QbD), continuous manufacturing, life cycle management, manufacturing innovation, data/knowledge management, risk assessment, as well as process control, modelling and chemometrics within the pharmaceutical industry.

IFPAC Cortona 2018, running from 7th -11th October, will focus on reducing the differences in pharmaceutical legislations and regulations between countries. Representatives from the FDA and EMA regulatory agencies will contribute to the discussion, helping businesses to improve industry harmonisation between the U.S. and Europe when implementing PAT strategies.

One of the key speakers will be Martin Gadsby, Director at Optimal Industrial Technologies, who will deliver a presentation on “Implementing PAT with Regulatory Compliance and Data Integrity in a Cyber Secure Framework” on Monday 8th October during the PM session on “IT & Data Information Management”.

During his talk, Gadsby will give an overview of the main challenges in regulatory compliance and cyber security currently being encountered. This includes the fact that a shift from batch to continuous manufacturing results in larger volumes of process data being generated. Also, that it is more important than ever for data storage solutions to address data integrity without affecting the security of existing software architectures. This will lead-on to PAT knowledge management platforms such as Optimal’s synTQ, that can provide a practical route to implementing a secure, compliant and successful PAT system.

synTQ provides robust storage and reporting of process data, instrumentation settings and control parameters. The software contains physical and procedural controls that protect the records within the system as well as guarantee that these are authentic, incorruptible, and confidential, where applicable. In this way, synTQ meets the regulatory requirements of the FDA, EMA and other regulatory bodies.

Optimal’s solution is well established as a market-leading tool and is used globally by the majority of the world’s largest pharmaceutical companies, hence according to its maker represents a useful tool to aid the harmonization of regulations worldwide.

Martin Gadsby commented: “Optimal has been heavily involved in the IFPAC community over the years, sharing our extensive expertise in the field. From a practical perspective our PAT software, synTQ, is helping pharmaceutical manufacturers to adhere to FDA and other regulatory guidelines while boosting their productivity and efficiency worldwide. We will be available throughout the event to discuss specific requirements and implementation questions around PAT.”

IFPAC Cortona will take place from 7-11 October 2018 – Centro Convegni Sant’Agostino, Cortona, Italy.

Image caption: At IFPAC 2018 the focus for software provider Optimal Industrial Technologies will be on its holistic knowledge management platform synTQ, which offers a regulatory compliant continuous production solution that is ready to be rolled-out.
(Source: Istock Copyright: Tzido - 829570660)

About Optimal Industrial Technologies Ltd

Optimal Industrial Technologies has more than 30 years’ experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries.

The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing; hence, the company’s primary aim is to deliver measurable improvements in all these target areas.

In addition to practical automation and system integration expertise Optimal Industrial Technologies has also developed a world leading PAT based data management software package – synTQ® which is used by over half of the world’s largest pharma companies to increase productivity and reduce time to market for OSD and biotech based drugs and therapies.

The image(s) distributed with this press release may only be used to accompany this copy, and are subject to copyright. Please contact DMA Europa if you wish to license the image for further use.

Editor Contact

DMA Europa Ltd. : Alan Hatch
Tel: +44 (0)1562 751436 Fax: +44 (0)1562 748315

Company Contact

Optimal Industrial Technologies : Martin Gadsby
Tel: +44 (0) 1454 333 222 Fax: +44 (0) 1454 322 240

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