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PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
28 & 29 November 2012
Course Programme:
Day One (9am – 5pm)
Background:
• What is a sterile product? Classification of products. Why are they
sterile?
• Basic microbiology and introduction of the term Sterility Assurance
Level (SAL)
• Regulations: Legislation and Governance and Annex 1
• Facilities and process design: Understanding airflows and
contamination control philosophies.
• Air Differentials
• Monitoring Personnel and airborne contamination levels. Viable and
non-viable contamination, techniques and the value of monitoring.
Day Two (9am – 5pm)
• Dosage Form Design: The role of the Target Product Profile, syringes,
ampoules, vials and other unique delivery systems
• Sterilisation: Methods of sterilisation, autoclave, dry heat oven,
radiation, filtration and EtOH exposure. The SAL calculation and
interpretation.
• Aseptic vs. Terminally sterilized: Benefits and drawbacks.
Registration. Handling implications and further processing.
• Process simulation and Validation: Post registration batches.
Validation activities. Impact of ICH and QbD.
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Organized by:
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PharmaTraining Ltd |
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Invited Speakers:
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Paul Cummings
Paul is a Chartered Biologist, a Fellow Member of the Society of Biology and has
nearly 30 years experience in the Pharmacy/Pharmaceutical Industry and left GSK in
2009 to pursue a career as an Independent Consultant. His latter roles at GSK were
“Head of Sterile Product Clinical Trial Supplies” and “Director of Product Development”,
working on new chemical entities from candidate selection through to market
launch and product line extensions.
He has broad international experience of product transfers, manufacturing and
registrations and can provide an invaluable resource to any company.
Paul was the recognised expert for the development of parenteral products with GSK
UK and was the named holder of the GSK manufacturing licence for Sterile Product
manufacturing in the UK until early 2009. He has substantial experience of
developing many different types of parenterals including: aqueous-solutions,
nonaqueous solutions, lyophiles, syringe prefills, ampoules, vials and radiolabelled
products. He has worked from the initial development activity stage, candidate
selection, through scale up and technical transfer into the factory network and has
expertise in validation and microbial assessment of the manufacturing process, risk
assessments and clinical trial designs.
He also has extensive experience of design and qualification of a sterile
development / production unit including environmental controls and contamination
controls.Paul has hosted FDA meetings, FDA pre-Approval inspections and MHRA
inspections. He has many years of experience leading trans-national teams based in
Japan, EU and USA for development of products for the Japanese and Worldwide
commercial markets. Paul was an Honorary Lecturer of Pharmaceutical Chemistry at
the University of Greenwich where he lectured on parenteral product development
as part of the BSc (Hons) Pharmaceutical Chemistry course until the course was
discontinued in c2004. He has also been a visiting lecturer on parenteral
development at the University of Kent.
He lectured on microbial spoilage, contamination control and sterility as well as
development of parenteral products and aseptic techniques.
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Deadline for Abstracts:
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Registration:
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Discounted rate for registering and paying before 3 October 2012
- 2 day course £1062.00 (+ VAT if applicable, see VAT NOTES)
Full Fee: 2 day course £1180.00 (+ VAT if applicable, see VAT NOTES) Discount of 10% applies for booking more than 1 delegate. Discount of 10% applies for booking more than
1 course. Maximum discount received is 15%
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E-mail:
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judy@pharma-training-courses.com
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