Good Engineering Practices for Pharmaceutical Systems: Design Aspects, Regulatory Considerations and Practical Issues

28-29 August 2012, Hyderabad
31 Aug.-01 Sept. 2012, Mumbai

This Workshop will explore Engineering Practices, with an overview from the European Union cGMP – EMEA, from the US cGMP – FDA/USP, as well as from international cGMP – WHO and PIC/S. The objective of this workshop is to focus
on current Good Engineering Practices in Pharmaceutical Systems used in the Manufacture of both, API and in Finished Pharmaceuticals, with GMP Impact i.e. Direct
Impact Systems. The Workshop material is updated as per current 2012 Regulatory and GEP Requirements.

WHY ATTEND THIS WORKSHOP ?
This Workshop will explore Engineering Practices, with an overview from the European Union cGMP – EMEA, from the US cGMP – FDA/USP, as well as from international cGMP – WHO and PIC/S. The objective of this workshop is to focus on current Good Engineering Practices in Pharmaceutical Systems used in the Manufacture of both, API and in Finished Pharmaceuticals, with GMP Impact i.e. Direct Impact Systems. The Workshop material is updated as per current 2012 Regulatory and GEP Requirements.

 YOU SHOULD ATTEND …
… If you are a Professional working with a Pharmaceutical Manufacturing Company in the field of –

• Pharmaceutical Projects and Engineering
• Manufacturing, Production and Technical Operations
• Quality Systems, Q.A. and Q.C.
• Validation, GMP and Regulatory Compliance
• Consultants and Suppliers of Engineering Solutions to Pharma Companies

 YOU WILL LEARN …

Day 1

 Day 2

 WORKSHOP LEADER

PAOLO CURTO
Paolo Curto is a Master of Science in Chemical Engineering and also has a National Qualification of Professional Engineering, and is a Qualified trainer certified from GMP School of Polish Government. Since 1997, he is with D.O.C., a Validation & Consulting Company for the Italian and International Pharmaceutical Industry, as Managing Director.

Paolo Curto has 25 years of international industrial experiences, working in Pharmaceutical Manufacturing
Companies, US-FDA approved, as Engineering & Validation Director, in Pharmaceutical Engineering
Companies and Pharmaceutical Equipment Suppliers Companies. He has technical expertise in the areas of Pharmaceutical Engineering & Validation, specializing in Development of Basic Engineering Design for new pharmaceutical facilities, complete Project Management including Engineering Design, Procurement,
Expediting, Construction, Commissioning & Start-up and Validation. He also has worked closely with the
Manufacturing Departments for Sterile Creams & Ointments, Sterile liquids and ointments, Parenteral lyophilized products among other dosage forms manufacturing, particularly with regards to Water System specifications. His experience also includes re-Engineering of several projects, involving revamping and automation of fine chemicals facilities.

Paolo has been invited to present several papers based on implemented Projects in the field of Pharmaceutical Technology at International Conferences and Seminars organized by reputed organizations – ISPE, PDA, PMA. Eng. Curtò is active in AFI, FIP-IPS, ISPE Italy and is a member of PDA Italy Chapter Steering Committee. He is a Qualified Trainer for several GMP Inspectorates in Italy, European Union, China and South America. Paolo is a permanent member of “Validation Task Force”, and has been actively involved during several pre-approval & GMP Inspections by various Regulatory Bodies, USFDA, PIC/S, UK.