Pharma 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.