Focus:
This SoCalBio workshop focuses on the FDA’s guidelines regarding Process Validation. It is designed for device and pharma regulatory affairs professionals to learn what is required to approach process validation from a life cycle perspective and incorporates modern risk management and quality systems tools and concepts.
Admission:
$350 Non-Member -- $250 SoCalBio Member
-- $200 Gov/Nonprofit/Academic
RSVP:
https://www.123signup.com/register?id=mqpmv
Speakers:
TBA
Agenda:
7:30 - 8:00 am
Registration and breakfast
8:00 - 8:15 am
Introductions
8:15 - 9:30 am
The FDA's guidance on process validation and what regulators are
now looking for
9:30 - 10:45
am Program design: process qualification
10:45 - 11:45 am
Program design: process verification
12:00
noon
Luncheon
1:15 - 2:30
pm Use of statistics for validation
2:45 - 4:00
pm Practical process validation issues:
company case studies
4:00 - 5:00
pm Workshop wrap-up
