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Date: 29th - 30th September, 2009

Location: Barnard Castle, Co. Durham, United Kingdom

Summary:
Clinical, Cosmetic, Pharmaceutical - Training, Seminar

The QP has a personal responsibility to ensure that they are adequately trained and that their industry knowledge is current. The MHRA is becoming particularly keen for QP's to be able to demonstrate that they are undertaking frequent and relevant CPD training programmes and many indemnity insurance companies now insist that policy holders maintain up-to-date training portfolios. For many individuals it is becoming increasingly difficult to stay abreast of the numerous changes occurring within the industry.

This intensive two day course will focus on providing delegates with the vital updates and changes that are happening within today's pharmaceutical, biotech and medical device industry.

Presented by people who are active in current industry and regulatory projects, and designed for QP's, Consultants, Senior Quality Managers/Directors and Contractors the course will provide a complete overview of the recent industry developments affecting the QP's role and can count towards your CPD. Intensive learning and group discussion will form the basis of the course delivery.

During the course, delegates will also have the opportunity to meet the Honeyman Group's unique team of Microbiologists, Chemists, Engineers and Validation Professionals and to ask any site specific questions they may have.

A certificate of attendance will be issued to each delegate upon completion of each day.

Proposed Course Content:
Please note that due to the nature of this course, the actual content may vary from that which is published here.
Each day will start promptly at 08.30hrs and finish at approximately 18.00hrs.

Day 1
Examining Quality Management Systems and Reviewing Recent Legislative and EU GMP Updates Encompassing

• Quality Risk Management
  


• Dedicated Facilities
  


• Document Management Systems
  


• Raw Material
  


• Sterile Products
  


• Biologicals
  


• Radio-Pharmaceuticals
  


• Medicinal Gases
  


• Herbal Medicines
  


• Computerised Systems
  


• Active Pharmaceutical Ingredients (API's)
  


• Investigational Medicinal Products (IMP's)
  


• Human Blood and Plasma Products
  


• QP Discretion
  

Focussing on the Requirements of a Pharmaceutical Quality System According to ICHQ10, Topics for Discussion Will Include:

• Management Responsibility
  


• Continuous Improvement
  


• Process Performance and Product Quality
  

Day 2
Analysing Additional Changes and their Resulting Implications, Incorporating:

• Regulatory Variations and Changes
  


• Clean Room Requirements
  


• Medical Device Legislation Updates
  


• Contract Manufacture and Supply
  


• Contract and Employee QP Expectations
  


• ICH Updates and Interpretations
  


• Anti-Counterfeit
  


• Distinctions and Updates on Expectations: GMP, GCP and GLP