Technical and FDA Regulated Trainings
Call us for more information on delivering one of the courses below or to customize a client-specific topic.
Regulations
Good Manufacturing Practices (GMP): The Basics I
Duration: Mini Session ½ Day; Full Course- 1 Day
Good Manufacturing Practices (GMP): The Basics II
Duration: Mini Session ½ Day; Full Course- 1 Day
Good Manufacturing Practices (GMP): Basics I: FDA Good Laboratory Practices and OECD Guidelines
Duration: Mini Session ½ Day; Full Course: 2 Day
Good Manufacturing Practices (GMP) Compliance: Laboratory Controls
Duration: Mini Session ½ Day; Full Course 1 Day
Title 21 CFR Part 11: The Basics I
Duration: 2 hrs
Validation & Qualification
Analytical Validation Requirements for GMP Compliance
Duration: Mini Session – ½ Day; Full Course 2 Days
Process Validation: The Basics for Bioprocessing
Duration: Mini Session ½ Day; Full Course 2 Days
Qualification of Equipment and Instruments (DQ, IQ, OQ, PQ)
Duration: Mini Session ½ Day (no exercises); Full Course 2 Days
Cleaning Validation and Compliance Issues for the FDA-Regulated Industries
Duration: Mini Session ½ Day; Full Course 2 Days
Stability
Stability Programs: What Required & Why?
Duration: 1 Day
Documentation
Basics of Writing Effective Standard Operating Procedures (SOPs)
Duration: Mini Session 1 Day (Introduction only); Full Course 2 Days
Writing Investigations & Deviations to Support GMP Incidents
Duration: Mini Session 1 Day; Full Course 2 Days
Contamination Control
Contamination Control: Manufacturing & Testing Environments
Duration: ½ Day; Full Course 1 Day
