Quality Managers (QM) and Qualified Persons (QP) need to make tough decisions every day. In fact, those decisions have an impact on the business and the quality of the product. Therefore, QMs and QPs must be a generalist and have an excellent understanding of the overall GMP quality system.
To be a good Quality Manager or Qualified Person in a GMP environment, you need to know how to:
- manage documentation correctly,
- write clear Standard Operation Procedures (SOPs),
- deal with deviations quickly and efficiently,
- investigate the root cause of issues effectively,
- evaluate, analyze and deal with risk in an appropriate manner,
- create useful CAPAs and establish a continuous improvement system across the organization,
- and manage all of the above with an adequate change control system.
It sounds complicated, but don’t worry- with our simplified and engaging Master Class, you will master all of the above within next year.
The 80-hours Master Class consists of seven workshops, which are spread across the year. Additionally, you will have the option the choose one of the available two dates to suit your schedule.
Topics: Root Cause Analysis
- Root Cause Analysis Overview
- Correct Documentation of RCA
- Impact / Risk assessment
- Team set up and planning
- Defining the problem
- Process flow map
- IS / IS NOT
- Cause and Effect
- 5-Whys
- Fault tree analysis
- Root Cause and Causal Factors
- Embedding the process
The workshop will allow you to align yourself with all the requirements of ICH Q10 and ISO 9001:2015 regarding events investigation.
Dates & Time
You can choose suitable session dates for you during checkout.
Every lesson begins at 09:00 (CET)
Deviations and Issue Management Systems Workshop
Sessions:
27 – 28 July 2021 (4 hours per day)
Corrective Actions and Continual Improvement Management System Workshop
Sessions:
21 – 22 September 2021 (4 hours per day)
Root Cause Analysis Process Workshop
Sessions:
01 – 04 June 2021 (4 hours per day)
Good Documentation Practice Workshop
Sessions:
09 – 10 March 2021 (4 hours per day)
07 – 08 September 2021(4 hours per day)
Change Management Systems Workshop
Sessions:
05 – 08 July 2021 (4 hours per day)
22 – 25 November 2021 (4 hours per day)
Quality Risk Managemen Workshop
Sessions:
10 – 13 May 2021 (4 hours per day)
08 – 11 November 2021 (4 hours per day)
Writing Standard Operating Procedures Workshop
Sessions:
13 -14 April 2021 (4 hours per day)
12 – 13 October 2021 (4 hours per day)
*Plus 30 minutes break per day.
