Core GMP Skills
BASIC Options
Interactive, virtual or on-site, instructor-led training on:
-
Customized or off-the-shelf cGMP application for new hires and/or annual refresher
-
Good Documentation Practices and Data Integrity
-
Basic contamination control and cleanroom behaviors
-
Inspection readiness
-
Change Control
HOLISTIC Options
-
Interactive new hire orientation program to quickly engage new employees and get them functioning in their roles quickly and effectively
-
GDP certification and annual refresher program
-
Robust, competency-based gowning qualification program, including annual refresher
-
Robust, competency-based aseptic program with input from internal SMEs
What VALUE can we bring to your organization?
-
Greater risk awareness
-
Improved compliance
-
Shorter door-to-floor time for new hires
-
Error prevention
Title: cGMP Application
Description
Not your usual ‘check the box’ GMP training!!
This course focuses on why it’s so important for us to follow cGMP standards and best practices, what those practices are for your firm’s products, processes, and business model, and how to apply them.
This interactive experience includes:
-
breakout sessions
-
polling
-
knowledge checks
-
loads of audience questions to engage participants in active learning.
The course also emphasizes Good Doc Practices in the context of Data Integrity standards, high-level contamination control (as applicable), and following written procedures, as well as ‘quick hits’ on key quality systems, such as:
-
Investigations & CAPA
-
Training
-
Human Error Prevention
-
Change Control
-
CMO oversight as needed for your application.
It also includes key habits for success and application exercises. Course can also be tailored to be an annual cGMP refresher or higher-level overview for non-technical employees as desired.
Duration: 3 – 4 hours
Note: All courses can be offered in person or in virtual format using MS Teams.
