About

LISA YEN, MS, director of regulatory and quality at Alembic LLC, has more than two decades of experience in the field of biotechnology and quality assurance. She has hands-on experience in process validation, conducting, auditing, and developing process validation and related quality system procedures. Previous positions include quality engineer positions at Velomedix, AngioScore, Boston Scientific, and Microlithography. Yen earned a bachelor’s degree in Chemical Engineering from the University of Washington and a master’s degree in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University.

Lisa Yen's courses currently open for enrollment

Medical Device Process Validation

MEDD.X411
$795
  • Live-Online Attend via Zoom at scheduled times.
Schedule
Date
Start Time
End Time
Meeting Type
Location
Wed, 02-11-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 02-11-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 04-01-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 04-01-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 02-25-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 02-25-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-04-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-04-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-11-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-11-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-18-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-18-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-25-2026
6:00pm
9:00pm
Live-Online
REMOTE
Wed, 03-25-2026
6:00pm
9:00pm
Live-Online
REMOTE
 

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

No meeting on February 18, 2026. To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

Required Text:
Quality Management Systems - Process Validation Guidance, 2nd ed., SG3, https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

Code of Federal Regulations Title 21 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

Associated Program(s)