Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>Events>This Event
  Events - November 2012


Introduction to Sterile Product Manufacture for New Starters and Junior Staff (2 day)

28 Nov 2012 - 29 Nov 2012 - Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG



Bookmark and Share


Course objectives
To provide training to personnel who are new to the Pharmaceutical or Biotech Industries and have no understanding of cGMP and who intend to work with sterile products, development, manufacturing, registration and facilities.

The course will include:
• A comprehensive background in sterile product manufacturing, regulations and facilities. • Adherence to cGMP and the consequences for non-compliance. • How to initiate development of new formulations, manufacturing, environmental and product monitoring. • Modes of sterilization and types of products.

Who should attend?
The course is ideal for new starters or junior staff working in the Pharmaceutical or Biotech industries who will be exposed to a sterile manufacturing facility or who will be involved in the development of new products. This is an introductory course and the level of detail will be as a broad based overview.
• Clinical Trials Manufacturing Scientists
• Development Scientists
• Regulatory Affairs Personal
• Pharmaceutical Production Personnel
• Quality Control and Quality Assurance Personnel

Course Programme:
Day One (9am – 5pm)
Background:
• What is a sterile product?
• Classification of products.
• Why are they sterile?
Basic microbiology. The Regulatory environment.
• cGMP
• Facilities and processing.
• The impact of personnel and materials
• Environmental Monitoring.
• What is the difference and the impact or viable and non-viable contaminants.
Day Two (9am – 5pm)
• Dosage Forms: syringes, ampoules, vials and others
• Sterilisation: Overview of methods of sterilisation, autoclave, dry heat oven, radiation, filtration and EtOH exposure.
• Aseptic vs. Terminally sterilized, how do you decide?
• Areas of specialization. Where do I go from here?

Course Speaker
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.

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%


Further information
Scientific News
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Gene Therapy for Metabolic Liver Diseases
Researchers have tested gene therapy in pigs from hereditary tyrosinemia type 1, with corrected liver cells being transplanted into the diseased liver.
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
New Medication Shows Promise Against Liver Fibrosis in Animal Studies
Liver fibrosis is a gradual scarring of the liver that puts people at risk for progressive liver disease and liver failure.
Raw Eggs Deemed Safe to Eat
A report published today by the Advisory Committee on the Microbiological Safety of Food (ACMSF) into egg safety has shown a major reduction in the risk from salmonella in UK eggs.
Monitoring TTX Toxin in Shellfish
In a number of small studies, mussels and oysters from the eastern and northern part of the Oosterschelde in Holland were found to contain tetrodotoxin (TTX).
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Gene-Editing 'Toolbox' Targets Multiple Genes Simultaneously
Researchers have designed a system that modifies, or edits, multiple genes in a genome at once while minimising unintentional effects.
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!