The increased use of disposable components in both manufacturing and packaging materials brings extractables and leachables to the forefront of required testing set forth by governing bodies.
Toxikon has seen a surge in demand for extractables and leachables testing to qualify the integrity of everything from single use systems to container closures.
Join us for this informative conference and learn more about the pressing issues within the industry and gain valuable insight from our staff of experienced professionals within the chemistry arena.
Where:
Toxikon Headquarters
15 Wiggins Avenue
Bedford, Mass. 01730
When: April 20, 2010
Registration fee: $249 per person; includes the cost of meals
Who Should Attend:
Designed for R&D, Regulatory and QA professionals, packaging developers and manufacturers of components such as vials/stoppers, prefilled syringes, MDI, tubing filters, bottles, drug delivery devices, bioprocess bags or other container closure systems.
Agenda:
8:30 a.m. Registration, Breakfast
9:00-10:30 a.m: Dr. Piet Christiaens, Scientific Director, Toxikon Europe, N.V. - How to Design an Extractable/Leachable Study: Using pre-filled syringes as a model, this presentation provides an introduction to analytical test methods used for E/L testing, the physics of polymer migration and common "do's and don'ts" to achieve successful outcomes.
10:30 - 10:45 a.m. - Refreshments, Break
10:45 - 12:00 p.m. Dr. Stephen Doherty, Manager, Chemistry Services, Toxikon Corporation - Extractables/Leachables in Quality Control Programs: From Raw Materials to Final Product: The assurance of the purity of a product begins with the purity of raw materials. This session reveals strategies for implementing extractable/leachable testing as part of the overall quality control process.
12:00 p.m. - 1:00 p.m. Lunch
1:00 - 1:45 p.m. John Iannone, Program Manager, Extractables/Leachables, Toxikon Corporation - Extractables/ Leachables as it Relates to Efficacy Testing for Combination Products: From drug-eluting stents to surgical mesh with coatings, these products require in-depth analysis since they represent a convergence of both drug and device. This session walks attendees through extractables and leachables testing methods relevant to combination devices.
1:45 p.m. - 2:30 p.m. Dr. Christopher Brynczka, Study Director, In Vivo Services, Toxikon Corporation - Risk assessment for Extractables/Leachables and Toxicology: This presentation provides insight into risk-based decision making from the perspective of a department manager who faces these challenges on a daily basis, and highlights study designs with successful outcomes.
2:30 p.m. - 3:00 p.m. Meet and greet with Toxikon's scientists, Q&A
3:00 p.m. - 3:30 p.m. Extractables & Leachables Inter-Relations: What happens when
compounds enter something as ubiquitous as a piece of plastic? Learn about compound inter-relations in a lab setting and find out how to safeguard your product in a lab setting.
3:30 p.m. - 4:00 p.m. Refreshments, Post-Show Surveys
Click here to access the seminar registration form. Please send completed forms to my attention via fax, email or postal mail. We look forward to seeing you at this year's event!
Joann Hoxha
Seminar Coordinator
Toxikon Corporation
15 Wiggins Avenue
Bedford, MA 01730
Phone: (800) 458-4141
Fax: (781) 271-1136
Email: Seminar@Toxikon.com
