Environmental Controls and Monitoring for ATMPs
Philadelphia has earned the nickname “Cellicon Valley” and is home to the some of the leading Advanced Therapy Medicinal Product (ATMP) manufacturers in the world. The manufacturing of ATMPs is evolving as more cell, gene and tissue-based therapies are discovered. Join ISPE DVC for an educational session led by Norman Goldschmidt of Genesis Engineers. Norm will focus this session on the environmental controls and monitoring necessary to manufacture these cutting-edge therapies while maintaining regulatory compliance.
The evening agenda is as follows:
- 5:00 - 6:00 pm: Attendee arrival, networking, and light buffet dinner
- 6:00 pm: Introductions, opening statements and presentation begins
- 6:15 - 9:00 pm: Presentation, open Q & A
In-person attendees will earn 3 Professional Development Hours for this session.
ISPE DVC will also offer a remote option for this education session. This option is designed for those that live far from the site and to reach markets beyond the Philadelphia area. Remote attendees will have the ability to earn 3 PDHs upon successful completion of a quiz administered at the end of the education session.
Speaker:
Norman Goldschmidt
Genesis Engineers
Mr. Goldschmidt has over 35 years of experience spanning the many types of facilities and processes necessary to bring a product to market, from R&D through manufacturing. Norman is internationally recognized as a life sciences expert and author with extensive experience in biopharmaceutical manufacturing and R&D including: sterile filling, vaccine and biotech API processing, cell & gene therapy, pharmacies and dispensing, and overall cGMP regulatory compliance.
Norman is an Author on six ISPE Guides and is a frequent speaker and instructor for ISPE, PDA, ASHRAE, NSF among others. Additionally, he has trained regulators across the world (FDA, USDA, HCA, TGA, MHLW). He holds 4 patents for innovations in HVAC and Pharmaceutical Processing and is an International Standards Organization (ISO) cleanroom delegate.
Registration Information:
|
COST |
|
|---|---|
|
ISPE Members |
$70 |
|
Non-Members |
$90 |
|
Young Professional/Student/Retired |
$45 |
| Webcast Only (ISPE Members) | $40 |
3 Professional Development Hours available.
*No walk-in registrations will be accepted for this event.