Research and Markets: Pharmaceutical and Biopharmaceutical Products Process Validation in the US and EU - Workshop, London, 10-11th February 2015

Research and Markets (http://www.researchandmarkets.com/research/2khmn6/process) has announced the addition of the "Process Validation in the US and EU (Workshop, London)" conference to their offering.

Date: 10-11 February 2015

The Rembrandt Hotel - London, UK

Key topics to include:

• Science and Risk Based Approach to Process Validation for Pharmaceutical and Biopharmaceutical Products
• Quality Risk Management
• FDA Process Validation Guidance
• EU Process Validation Guideline
• EU Draft Annex 15
• Lifecycle Approach to Process Validation Process Design
• Equipment and Utility Qualification Process Performance Qualification / Process Validation Continued Process Verification / Ongoing Process Verification
• Continual Improvement and Process Optimisation Process Improvement
• Implementation Challenges
• Business Benefits

Benefits In Attending:

• Understand the link from product requirements, to equipment verification and process validation
• Understanding the similarities and difference between process validation expectations in EU and US
• Establish a Process Validation programme
• Understand the link between Quality by Design and Process Validation
• Gain a practical, science and risk based approach to Process Validation including Equipment Verification
• Apply relevant tools for Process Validation, such as Risk Assessments, Design of Experiments and Statistics
• Gain knowledge in Good Engineering Practice (GEP)
• Unscramble the real meaning of buzz words' such as Qualification, Verification, Commissioning, Validation etc.
• Realise significant business benefits from a science and risk based approach

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 including:

• 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

For more information visit http://www.researchandmarkets.com/research/2khmn6/process