Continuing Education – Evening Lecture
A Step-wise Methodology for Cleaning Process Development Using Design of Experiments
Speaker:
Keith Bader
Monday December 12, 2016
5:15pm-5:30pm – Brief Networking & Dinner
5:30pm-6:15pm – PDH Lecture
6:15pm-6:30pm – Q&A Session
Location:
Third Floor Main Conference Room
Two Ash St. Suite 3000
Three Tower Bridge, Jacobs Engineering
Conshohocken, PA 19428
Directions
Price:
$35 Non-members & Guests
$30 (Members)
$15 (Students)
$15 Webex option – Please select from Drop down menu and Laura-Ann Chin (lchin@geieng.com) will be in contact with follow up webex info.
Dinner will be provided with registration.
PDH Credit: 1 credit
Abstract
Many cleaning processes have typically been developed at commercial scale concurrent with production, resulting in cleaning cycles often lacking a strong basis in science. Recent FDA and ICH Q8 guidance describes the application of front-loaded quality by design concepts for pharmaceutical development. Developmental work at the bench scale can provide a scientific basis for the cleaning process, and can be employed in conjunction with ICH Q9 risk management approaches to provide a basis for the extent and scope of cleaning validation requirements at lab, pilot and manufacturing scales. Through the use of Design of Experiments, it’s possible to achieve greater efficacy and efficiency. These concepts can be applied for the selection of cleaning agents, the development of a cleaning process design space, and initial parameter discovery tests, thus providing a basis for strategic and tactical decision making.
Biography
Keith Bader has nineteen years of years of experience with specific expertise in project engineering, aseptic process engineering, cleaning process development, and cleaning validation, cleaning reviews and gap assessments as well as Pre-Approval Inspection (PAI) Readiness.
Through the years, he has provided high level consultation to Hyde’s Engineering's clients in topic areas ranging from strategic quality and validation documentation architecture to detail oriented support such as design of experiments and supporting study design. Keith has focused in recent years on the implementation of online instrumentation and process analytical technologies for clean-in- place systems, as well as the translation of bench scale cleaning process development data to full scale manufacturing systems.
Leveraging this expertise, Keith founded Hyde’s CORE Lab in 2012, a facility devoted to the development, exploration, and scale up of cleaning processes for the pharmaceutical and biopharmaceutical industries.
Keith has also published multiple journal and periodical articles as well as chapters in PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design by Duncan Lowe, and in Cleaning and Cleaning Validation, Volume 2, edited by Dr. Paul Pluta.
Registration:
Please register no later than Monday December 12 at 5:15 PM. Cancellation requests received by the registration deadline will be fully refunded.
Should you have any further questions, please do not hesitate to reach out to Laura-Ann Chin at lchin@geieng.com 520-275-4152 (Mobile).