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On-Line Training For Refresher cGMP Training

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On-Line Training For Refresher cGMP Training Pharmachemical Ireland Presentation Dublin 25th May 2010 Prepared by: Suzanne O Leary (QA Specialist) – PowerPoint PPT presentation

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Title: On-Line Training For Refresher cGMP Training


1
On-Line Training For Refresher cGMP Training
  • Pharmachemical Ireland Presentation
  • Dublin 25th May 2010
  • Prepared by Suzanne OLeary (QA Specialist)

2
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.
  • Suzannes 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.

3
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.

4
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.

5
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 Oct08,
  • Site contamination issue
  • IMB Inspection trends 2000-2007

6
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

7
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)

8
cGMP Refresher Training at NRL E-Learning
2009-2010
  • Show extract of the training package.

9
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.

10
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.

11
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)

12
Feedback from the plant Improvements?
  • Doesnt 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)
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