Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
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
Spero Therapeutics Announces $30 Million Series B Preferred Financing
Company has announced financing of $30 million to support development of novel therapies to treat gram-negative bacterial infections.
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Nanoparticles Deliver Tumor Suppressors to Damaged Livers
UT Southwestern Medical Center chemists have successfully used synthetic nanoparticles to deliver tumor-suppressing therapies to diseased livers with cancer, an important hurdle scientists have been struggling to conquer.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
A New Type of Anticancer Agent
Success in the development of a ?-tubulin specific inhibitor.
Nanoparticles Proven Effective Against Antibiotic-Resistant “Superbugs”
In the ever-escalating evolutionary battle with drug-resistant bacteria, humans may soon have a leg up thanks to adaptive, light-activated nanotherapy developed by researchers at the University of Colorado Boulder.
Scroll Up
Scroll Down
SELECTBIO

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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!