Research and Markets (http://www.researchandmarkets.com/research/s4vjlc/process) has announced the addition of the "Process Validation for Pharmaceutical Products Regulated by EMA & FDA - Balancing Science and Risk During the Product Lifecycle (Seminar, London)" conference to their offering.

The Process Validation for Pharmaceutical Products Regulated by EMA & FDA seminar will take place on the 27th & 28th February 2014 at the Rembrandt Hotel, London

SOME OF THE KEY TOPICS TO INCLUDE:

- Science and risk based approach

- ICH Q8, Q9, Q10 and Q11

- Validation activities across the product lifestyle

- The EU Process Validation guideline

- Annex 15 and its anticipated changes

- The FDA Process Validation Guidance - process design, process qualification, continued process verification

- Quality risk management (ICH Q9)

- Pharmaceutical Quality System (ICH Q10)

- Equipment qualification in relation to process validation

This two day seminar will include practical workshop exercises.

WHO SHOULD ATTEND

This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:

- Development

- Manufacturing

- Engineering

- Quality

Personnel from the Pharmaceutical and Biopharmaceutical Industry:

- Process Engineers

- Pharmacists

- Scientists

- Quality Assurance Professionals

- Quality Control Managers

- Late Stage Product and Process Development Engineers, Scientists, Pharmacists

- Technology Scale up and Transfer Managers

- Validation and Qualification Managers

- Validation and Qualification Specialists

- Risk Management Specialists

- Lean Management Specialists

- Operation Managers, Engineers

A Certificate of Attendance for Professional Development will be given to each participant who completes the course

DATES:

27 February 2014 Start: 09.30 - Finish: 17.00

28 February 2014 Start: 09.00 - Finish: 17.00

REGISTRATION & COFFEE

27 February 2014 09.00

VENUE & ACCOMMODATION

The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS

DIRECTIONS:

Opposite V&A Museum. Nearest underground station: South Kensington.

NOTE: Events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged

For more information visit http://www.researchandmarkets.com/research/s4vjlc/process

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Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals