Barrier Isolation Technology Forum: Innovation, Updates, and New Case Studies (E01)
| 7-8 June CEUs: 1.2 |
 |
 |
 |
Sponsored by the SPP Community of Practice.
This seminar presents developing technology and regulatory perspectives for barrier isolation, especially in regard to advanced aseptic processing, restricted access barrier systems (RABS), and isolators. Case studies bring the latest applications in the field. Content includes multiple case studies and interactive workshops on topics of global importance. Content includes background on four technology updates and seven case studies. Three interactive workshops provide access to discussion topics of global importance. Hear from speakers from Europe and North America, and participate in an FDA question and answer session.
This year will feature a variety of topics including robotics, E-beam sterilization of syringe tubs, measurement of hydrogen peroxide, biological sensitivity to hydrogen peroxide, clinical trial materials produced in an isolator, a biotech facility using isolator, and several contract manufacturing examples using these techniques.
This seminar features information that is generally between intermediate and advanced levels; however, it is very suitable for less experienced professionals as well.
How You Will Benefit:
At the conclusion of this session, participants will be able to:
- Describe updated technologies applicable to advanced aseptic processing using BFS, RABS and barrier isolation
- Describe how robotics can improve clinical manufacturing
- Understand protein sensitivity to hydrogen peroxide
- Interpret regulatory agency perspectives to streamline your regulatory submission and approval process
- Participate in peer discussion groups on advanced aseptic processing issues
- Understand what to do and what not to do from those who have done it before
- Apply best practices from case studies
Who Should Attend:
All aseptic processing professionals wishing to stay at the forefront of barrier isolation technologies.
Leaders
- Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
- Michael Porter, Dir., Technical Operations, Merck & Co Inc, USA
Speakers
- Dieter Bachmann, Head Quality Validation, Cilag AG, Switzerland
- Dieter Bandtel, Product Manager, Bosch Packaging Technology, Germany
- Sarah Doshna, Director, Clinical Manufacturing, Bristol-Myers Squibb, USA
- Tara Gooen, LT, PHS, Team Leader, FDA/CDER/DMPQ, USA
- Ryan Hawkins, Manufacturing Manager, Cook Pharmica, USA
- Thomas Huber, Dipl. Ing Eth, Sales Director & Deputy To the CEO, Skan AG, Switzerland
- Sterling Kline, R.A., Director, Project Development, IPS, USA
- Mathias Kreher, Product Manager, Bosch Packaging Technology, Germany
- Patrick Poisson, Vice President Mfg, Fill/Finish, United Therapeutics, USA
- Robert Sausville, Supervisory Consumer Safety Officer, FDA/CBER/OCBQ/DCM, USA
- Destry Sillivan, Sr. Regulatory Review Officer, FDA, USA
- Barry Starkman, Plant Manager, Genentech, USA
- Chris Wacinski, Director of Engineering, Jetalon Solutions Inc., USA
- Michael Walsh, PhD, Senior Research Scientist, Eli Lilly & Co, USA
- Sokhorn Yim, Pharma & Packaging Engineer, Genentech, USA
Communities of Practice (COPs):
- SPP - Sponsor
- Biotech
- C&Q
- Containment
- Disposables
- Investigational Products
- Product Process Development
Knowledge Elements:
- 1 - Product Development
- A. Formulation, clinical phases, and manufacture
- 2 - Facilities and equipment
- A. Design and construction/installation
- C. Operation and maintenance
- 5 - Production systems
- A. Production unit operations - drug (small molecule) and biologics
Related Technical Docs and/or PE, JPI articles:
- ISPE Baseline® Guide: Sterile Manufacturing Facilities
- ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
- ISPE Knowledge Brief: Risk-Based Approaches to Cross Contamination
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.