ISPE to host event on pharmaceutical control

An ISPE product story

Edited by the Engineeringtalk editorial team Jul 26, 2010

ISPE will be hosting the ISPE Brussels Conference, entitled 'Risk-based Control Strategies in Pharmaceutical Industries', at the Sheraton Brussels Hotel on 20-23 September 2010.

At the ISPE Brussels Conference, the 'Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products' (Risk-Mapp) will be launched.

Attendees will receive a free copy of the guide with paid registration.

In preparation for the Risk-Mapp seminar, delegates are encouraged to attend a live webinar, entitled 'Risk-Mapp: What it is and why you need it' on 14 September 2010.

Risk-Mapp provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

For those involved with multi-product facilities, this document is said to be an essential tool in understanding and controlling the risk of cross contamination, while also protecting the operator.

The conference seminars are as follows: Barrier Isolation Technology Forum - Innovation, Updates, New Case Studies; Dedicated Facilities, Cross Contamination and the Risk-Mapp Approach; GAMP - A Guided Tour of the World of Good Practice Guides; PQLI - Case Studies in QbD for Biotechnology and Small Molecule Product Realisation; Containment - The Devil is in the Detail; Investigational Products (IP) - Lean and Compliant Applying Efficient Tools to a Regulated Clinical Supply Chain; and Science and Risk-Based Commissioning and Qualification (CandQ) - Transitioning and Transforming.

The training courses are as follows: Sterile Drug Manufacturing Facilities - Applying ISPE Baseline Guide and FDA Guidance Principles to Design and Operation; and Practical Application of Computerised Systems Compliance GAMP 5 (including an online course).

The event will also include the sponsorship and tabletop exhibits of a range of suppliers of pharmaceutical manufacturing, as well as networking events for pharmaceutical industry professionals.