A biopharmaceutical manufacturer engaged SeerPharma to provide on-going coaching to their Quality personnel and advise on improvements to help prepare for a FDA inspection.
The program :
- Provided support to existing Quality personnel
- Fast Tracked their Professional Development in to key Quality Assurance positions
- Reviewed the existing Quality Management System
SeerPharma’s program brought together elements of Training, Coaching, and Mentoring:
GMP TRAINING
Over the course of our deployment, SeerPharma provided a structured training program for the personnel touching on areas such as:
- The Evolution of GMP Quality Management Systems: from QC to GMP to QA to QS
- Total Quality Management/Continuous Improvement/Lean Manufacturing
- Quality Risk Management
GMP COACHING
Over the course of the deployment, SeerPharma provided formal guidance on specified quality / compliance activites, such as:
- Procedure Writing
- Problem Solving
- Risk Assessments
- Lean Manufacturing
GMP MENTORING
SeerPharma was a sounding board and advised as required to agreed Service Levels.
A number of clients have approached SeerPharma for a similar style of engagement and in response, we’ve constructed the following Coaching Program options that are deployed over a 3-month period:
|
Full Business Coaching Program |
Half Business Coaching Program |
Mini Business Coaching Program |
|
Six (6) Days of Face to Face Coaching/Mentoring Twenty Four (24) 1-hour business coaching sessions, except holidays Weekly reports on staff development |
Three (3) Days of Face to Face Coaching/Mentoring Twelve (12) 1-hour business coaching sessions, except holidays Fortnightly reports on staff development |
One (1) Day Face to Face Coaching/Mentoring Ten (10) 1 hour business coaching sessions, except holidays |
Contact us if you’d like to use our expertise to bring staff up to speed in an expedient fashion and you would like to learn more about our GMP coaching program.
This post comes from our July 2016 Journal. You may also be interested in these posts:
- FDA and TGA GMP Inspection Help for Pharmaceutical Company
- Implementing FDA, EMA and PIC/S GMP
- GMP Training for Bioprocessing Technology Institute Singapore
- QMS Help for Biotech and Medtech Start-ups
- Pharmaceutical Quality Management System Solutions
