January 24, 2008 1

QP Training SurveyOn behalf of the PQG

Presented by Samantha Clack

27th November 2007

January 24, 2008 2

Factoids

• UK has one of the most stringent requirements for QP Certification in Europe

• There are 1508 registered QP’s in the UK !!

• 483 (32%) of these are eligible under the Permanent Provision

• There are more leaving the register than joining

• QP Viva Pass rate in 2006 – 68%

January 24, 2008 3

4831508TOTAL

146244IOB

47569RSPGB

290695RSC

Permanent Provision Eligible

Registered QP’s

Society

Factoids

January 24, 2008 4

Background

How effective is current QP Training?

• 8 Questions• 15 active QPs interviewed by phone

• 30 min questionnaire• mix of qualitative and semi-quantitative feedback

January 24, 2008 5

Interview Questions

• How long did QP Training take?• How long have you been an active QP?• Which course did you attend?• Did you do any supplementary training in addition to course?

• How well did the course prepare you for the viva?• How well did the course prepare you for the QP role?• How useful was the role of your sponsor?• Are there sufficient support networks for QPs?

January 24, 2008 6

Interviewee Background

ExperienceYears in Industry: Average 14

Range 7 – 22QP TrainingTraining Time: Average 2 yrs 10m

Active QP: Average 2 yrs Range 6 m – 3.5 yrs

Only one failed viva first time round

January 24, 2008 7

Course Providers Used

David Begg Associates (DBA) – 5 interviewees• Modular Course 12 one week residential courses

24 month duration• Includes one practical module and Mock Viva• Option to complete Post Graduate Diploma inPharmaceutical Science with the University of Strathclyde

RSSL – 1 interviewee• Modular Course 12 Modules

1 – 3 days duration• Can complete within 12 months

RSSL/DBA COMBO - 4 interviewees

January 24, 2008 8

Course Providers Used

University of Brighton – 4 Interviewees• 24 month course 6 residential weeks • Practical sessions included• Post Graduate Diploma in Pharmaceutical Science

University of Sunderland – 1 interviewee• Post Graduate Diploma in Pharmaceutical Science

University of Greenwich – 0 interviewees• Post Graduate Diploma in Pharmaceutical Science

January 24, 2008 9

Additional Training

• In-house training courses on specialist subjects such as aseptic/sterile manufacture, microbiology, regulatory

• Work shadowing in laboratories

• Visits to other company’s facilities manufacturing other dosage forms mainly Clinical Trials, Steriles, API’s and Packaging

• PQG, ISPE Seminars

• Members of interest groups internal/external

• ISO 9000 courses and participation in external audits

• In-house mock viva and scenario question discussions

January 24, 2008 10

Preparation for Viva/QP Role

32SUNDERLAND

2.52.75BRIGHTON

2.83.2RSSL

3.83.8DBA

PREPARATION for QP ROLE

PREPARATION for VIVA

COURSE PROVIDER

Rating of 1- 5 1 = Very Poor 5 = Very Good

January 24, 2008 11

Preparation for Viva/QP Role

DBA Delegates Feedback• Good opportunities to share experiences• Real life scenario based exercises • Holistic views presented• Soft Skills Tutorials provided • Course materials provided good reference materials• Engaging presentations• Good for building QP Network• Tutors - high calibre/very knowledgeable, experienced in industry

• Mock Viva included• Assignment of a DBA tutor/mentor

January 24, 2008 12

Preparation for Viva/QP Role

DBA Delegates Feedback• Increase scenarios• Reduce complicated technical detail; overwhelming, confusing

• More practical sessions - how to apply technical knowledge in practice

• More opportunity for sharing experiences with other delegates

• Reduce replication between modules • Cost!!

January 24, 2008 13

Preparation for Viva/QP Role

RSSL Delegates Feedback• Can complete within 12 months• Provides basic information on subject • Lecturers available for discussions• Good opportunities to share experiences• Good if already knowledgeable or have experience in area

• Good for major take home messages

January 24, 2008 14

Preparation for Viva/QP Role

RSSL Delegates Feedback

• Gave basics only, knowledge required

• Practical applications/insights needed

• Use of visual aids would be beneficial

• More on how to apply theoretical knowledge in practice

• No support/advice on viva preparation

• Lecturers variable in their knowledge

• Some information was dated

• Course felt rushed

• Mock Viva is extra cost

January 24, 2008 15

Preparation for Viva/QP Role

Brighton Delegates Feedback• Good Practical modules • Organised visits to pharmaceutical sites• Lecturers had some input from industry• Structured Course • Presented in a manner which enables broad understanding of topic

January 24, 2008 16

Preparation for Viva/QP Role

Brighton Delegates Feedback

• Academically based

• Tutors were mainly academics

• Little practical or real life experiences shared

• More on how to apply theoretical knowledge in practice

• No QP scenario discussions

• Doesn’t prepare you for role

• Minimal preparation for Viva

• Old material

• Did not cover ‘water’ – a major raw material

January 24, 2008 17

Role of the Sponsor

Effectiveness dependant on

• Individual Sponsor

• Understanding of candidates needs

• Understanding of process and requirements

Average Rating

3.33

January 24, 2008 18

Role of the Sponsor

Delegate’s requirements of Sponsors:• Understand the role as a sponsor and the QP application process

• Ideally have been through process• Complete candidate knowledge gap analysis against Study Guide

• Prepare development plan and review progress • Expedite/support additional training requests • Use network contacts to help with training• Guidance and preparation for the viva

January 24, 2008 19

Role of the Sponsor

Delegate’s requirements of Sponsors:

• Organise, set-up and participate in in-house mock vivas

• Discuss scenario questions

• Encourage Trainee QPs to participate in any internal QP meetings

• Critically evaluate application form and identify areas for improvement

• Supportive and encourage candidates

• Keep up to date with current Hot Topics and Regulatory changes

January 24, 2008 20

Role of the Sponsor

Key Messages:

• The expectations for Sponsors are NOT clear• Sponsors should be obliged to attend a training session which would explain their role and how to go about supporting a trainee QP

January 24, 2008 21

QP Networks

Current Networks available

• European QP Association• DBA QP Alumni• PQG Website/Forums

January 24, 2008 22

QP Networks

Delegate feedback• Dependent on course completed • PQG Trainee QP seminars beneficial

• No 1 network that all QPs belong to

Suggestions• Web based discussion forum advantage • Low Cost, informal, QP Forum for open discussion on grey decisions

January 24, 2008 23

Other Comments

• Training Providers are providing training!!• Responsibility of the individual and sponsor must

• Identify knowledge gaps• Gain relevant experience• Fulfil Study Guide Requirements

• More soft skills training i.e. presentation skills, conflict management

• Guidance on fulfilling CPD requirements • Guidance on grey area decisions from regulators• Streamlining of QP Application Process across Europe

January 24, 2008 24

Key Conclusions

• Training courses• Focus on real life scenarios• Incorporate theory into practice• Include Soft Skills

• Training and guidance for Sponsors • Informal network for all UK QPs • Guidance on CPD requirements should be more detailed and suggest low cost options to fulfil these

January 24, 2008 25

Thank You!

Questions?