Transcript Novartis Suzanne O`Leary

On-Line Training For Refresher
cGMP Training
Pharmachemical Ireland Presentation
Dublin 25th May 2010
Prepared by: Suzanne O’Leary (QA Specialist)
An Introduction
 The Novartis Ringaskiddy site (NRL) is an Active Pharmaceutical
Ingredient (API) Manufacturing Site, based in Ringaskiddy, Cork.
 It is a Swiss owned company employing approx. 450 NRL staff.
 NRL operates a 4 Cycle Shift.
 Suzanne’s experience at NRL:

Worked at NRL for 13 years.

Worked in Compliance/QA in various roles over the 13 years.

Currently working as a QA specialist responsible for batch release support,
providing support to on-site investigations and acting as site-wide GMP Training
Coordinator since 2004.
2
cGMP Refresher Training at NRL: Years 2006-2008
 For the 3 years previous to the introduction of the e-learning package, the
following topics were covered for Refresher GMP Training:
 2006:
 QA/Compliance Dept received specific cGMP training given by an external
contractor Val Mulholland from GMP Services. Mainly covering regulatory trends.
 The rest of the site were trained by QA with a session entitled ‘GMP Why Do We
Need it’. This session covered:
 A video detailing how laws were introduced historically by the FDA.
 Overview of the IMB.
 IMB and FDA Audit Trends.
 Overview of a recent Corporate Audit.
 Documentation Rules.
3
cGMP Refresher Training at NRL: Years 2006-2008
 2007
 Function Heads and Managers were again given a specific cGMP
training given by an external contractor Val Mulholland from GMP
Services.
 The rest of the site were trained by QA using approved training
packages which covered:
 Discuss the IMB Audit Findings Feb 2007.
 Overview of NRL Complaints.
 Documentation Rules combined with assessment of same.
 Validation Overview combined with a discussion forum on same.
4
cGMP Refresher Training at NRL: Years 2006-2008
 2008
 A slightly different approach to Refresher was taken, after a site wide review it
was decided that the following 4 training sessions were acceptable as
Refresher cGMP training in 2008:
 IQP (Innovation,Quality,Productivity) Bronze training: This was process improvement
training.
 AQWA Change Control Training: New Change control system was
introduced on site, combined with detailed training on change control.
 ‘5 S PROJECT’: Training in Good Housekeeping practices on plant.
 Anyone who had not attended IQP/AQWA or 5 S Project training in 2008 were
trained by QA in a Refresher cGMP Training package which covered:
• Overview of FDA Audit Oct’08,
• Site contamination issue
• IMB Inspection trends 2000-2007
5
cGMP Refresher Training at NRL: E-Learning 2009-2010
 It 2009 we rolled out a new e-learning package for Refresher cGMP
Training.
 The e-learning package was developed by Good Training Practice
(GTP) International Ltd in the UK for Novartis Grimsby Ltd.
 This e-learning package consists of 8 GMP modules:

Overview of GMP

GMP-Personnel

GMP-Responsibilities

GMP-Deviations

GMP-Change Control

GMP-Contamination

GMP-Computer Systems

GMP-Documentation
6
cGMP Refresher Training at NRL: E-Learning 2009-2010
 Novartis Ringaskiddy Ltd (NRL) reviewed these 8 modules and
updated the content to reflect NRL specific requirements.
 Only minor changes were required resulting in a huge cost reduction
for our site.
 NRL plan to use these 8 GMP modules to Roll out Refresher cGMP
training over the next 3 years as follows:

Overview of GMP (2009 Refresher cGMP Training)

GMP-Personnel (2009 Refresher cGMP Training)

GMP-Responsibilities (2009 Refresher cGMP Training)

GMP-Deviations (2010 Refresher cGMP Training)

GMP-Contamination (2010 Refresher cGMP Training)

GMP-Change Control (2011 Refresher cGMP Training)

GMP-Documentation (2011 Refresher cGMP Training)

GMP-Computer Systems (AIT Specific Training)
7
cGMP Refresher Training at NRL: E-Learning 2009-2010
 Show extract of the training package.
8
cGMP Refresher Training at NRL: Advantages
 The training is run through our Learning Management System (LMS)
(‘Pathlore’).
 Trainee e-signs at end of training, No Paper!!. Training completion including
assessment is captured on the LMS. (21 CFR part 11 compliant)
 People complete their training at their desk or at a PC in the various control
rooms around the site.
 People can do the training at a suitable time, flexible. (7 days/wk, days/nights)
 You can start the training, stop it go away and resume the training again
e.g. if an urgent sample comes into lab!
 People can do the training at their own pace, often not possible to ensure
this in a class room setting.
 Mandatory training is completed and can free up time for GMP trainers to
perform specific training as requested by process units. E.g. Batch record
training at NRL.
9
cGMP Refresher Training at NRL: Disadvantages
 Not everyone has easy access to a PC:
Solution: I run some class room sessions to accommodate these groups, e.g.
Craft. However this does not take too much time.
 Some people prefer the Human factor, to have a trainer present
for questions etc:
Solution: However I go around the various control rooms on a regular basis or
ask people to call me if they have questions or difficulties starting the training.
Again this does not take much time.
 Training covers sidewide issues, some people want specific
training with specific examples:
Solution: Using e-learning packages frees up previously very busy GMP
trainers who can now concentrate on providing specific training to various
process units/ departments.
10
Feedback from the plant: Strengths
 ‘Saves time as you can access at your PC at your own time’ (Lab personnel)
 ‘’Good Quality, Course content appropriate, can go back over if necessary’ (Lab)
 ‘Quick, can be done when you have time, can be paused and started again’ (Lab )
 ‘You can do the course at your own specified convenient time’ (Equipment
Qualification Personnel)
 ‘Being able to complete the course at a time that suits me. Also this course lends
itself perfectly to a web based training package’ (Production Personnel)
 ‘Do it when you have time to do it, not at a specified time’ (Production)
 ‘User Friendly, Clear and understandable, good use of graphics/Animation’
(Production Personnel)
 ‘Gives People time to do training at their own pace’ (Engineering Personnel)
11
Feedback from the plant: Improvements?
 ‘Doesn’t need to be improved’ (QA & Production)
 ‘Possibly having more area specific as opposed to site specific’ (Engineering
& Production)
 ‘Being less Monotone’ (Lab)
 ‘Making the course more difficult, questions were easy’ (Lab)
12