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GMP The Fundamentals and Regulation.

CANCELLED - This 5 day residential “hands on” practical course is aimed at pharmaceutical and healthcare professionals who wish to increase their knowledge and understand the GMPs as they relate to the pharmaceutical industry. Delegates will gather information about European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. Delegates will also benefit from daily practical sessions within the microbiological laboratory.

 

Course Overview

Keeping abreast of today’s changing GMP requirements can be a challenge for those involved in sterile pharmaceutical production. This intensive course will provide you with detailed background information in order to understand and implement GMP best practice back in the workplace. Running for over 20 years, this highly successful course provides a unique opportunity not only to understand the fundamentals and regulation of GMP but also to give hands on experience in microbiological laboratory.

Click here for download of programme

Benefits of Attending

The course is structured to promote delegate discussion and debate. Workshops are a key feature where knowledge gained can be tested and applied. Laboratory sessions provide a useful insight into not only microbiological testing sessions and their limitations but also  interpretation of results. Delegates attending the course will be well equipped with  knowledge of how to prepare for and handle a regulatory inspection.

Who Should Attend?

The Course will be appropriate for production supervisors, engineers, quality control, regulatory affairs and validation staff who are newcomers to the field of sterile  pharmaceutical product technology. The programme will give those attending a basis on which to develop their knowledge and expertise. This course is limited, so book now to avoid disappointment.

MONDAY September 17th

• Introduction to Quality of Medicines
• GMP Pharmaceutical Law EU and FDA
• Introduction to Microbiology
• Microbiological Control of Medicines and Monitoring
• Laboratory Practical

TUESDAY September 18th
• Principles of Sterilisation
• Types of Sterilisation
• Documentation
• Documentation Workshop
• Laboratory Practical, including Demonstration

WEDNESDAY September 19th
• Sterilisation Workshop
• Quality Audits and Inspections
• Good QC Laboratory Practice
• Laboratory Practical, including Demonstration

THURSDAY September 20th
• Annex I of EU GMP
• Pharmaceutical Water Systems
• Complaints and Recalls
• Plant Maintenance Planned and Breakdown
• Laboratory Practical
• Course Dinner at local Restaurant

FRIDAY September 21st
• Workshop on FDA Warning Letter
• Role of QP

PRACTICAL SESSIONS
• Basic microbiological techniques – aseptic transfer using pipettes, glassware, bacteriological loops etc.
• Sampling from natural environment: raw materials, water surfaces, atmosphere, operators. Use of dip slides, contact plates, settle plates, finger dabs.
• Growth promotion test on media.
• Sterility test exercise to demonstrate statistics and problems of sampling.
• Particle counting in liquids and air (invited speaker).
• Pyrogen test (LAL Test) on different types of water (invited speaker).
• Results reading from Practical 1 and exercises,1,2 & 3.
• Identification of selected microbial isolates (from results of Practical 1) – microscopy and staining:
• Gram stain; spore stain; phase contact.
Commercial identification systems.e.g. API – selective and diagnostic media.
• Discussion of statistics/sampling theory re sterility tests.

A timed programme will be issued along with the confirmation letter. This can be subject to change.

Accommodation
Accommodation will be included in the course fee; rooms will be automatically booked for each individual. All rooms will have en-suite facilities. Location details will be sent out with a confirmation letter upon receipt of booking.

Cancellation and Refunds
Confirmed registrations cancelled 20 working days in advance of the course date will receive a full refund, 15 days, 50% refund and cancellation within 10 working days or less of the course date
will be subject to the full attendance fee. Substitution may be made at any time.

Venue

The Univeristy of Bath, Claverton Down, Bath

Speakers

Mr. Gerry Prout - Kennet Bioservices Ltd
Mr. Mike Zaccheo - Zac-Tec Bioservices Ltd
Dr. Rosamund Baird - School of Pharmacy & Pharmacology, University of Bath
Dr. Abdu Ahmed - CoAcs
plus Guest Speakers

Date

September 17 - 21, 2012

Enquiries

Please contact PHSS office for any questions.

Costs

Member £ 2450.00 + VAT
Non Member £ 2650.00 + VAT

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