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