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Registered Charity Number 207890Copyright © Royal Society of Chemistry 2015
Registration OfficerMembership and Qualifications
Telephone: 01223 432690Email: [email protected]
Royal Society of ChemistryThomas Graham House, Science Park,Milton Road, CambridgeCB4 0WFwww.rsc.org
Continuing Professional Development
Specialist SkillsCPD for members on the RSC Register of Eligible Qualified Person
Specialist Skills QP 2013 page 1
Guidance Notes for CPD for Eligible Qualified Persons
The RSC defines Continuing Professional Development as "The responsibility of individuals for the systematic maintenance, improvement and broadening of knowledge and skills to ensure continuing competence as a professional throughout their career".
As a QP, recording your CPD will identify your commitment to maintaining your professional competence, as required by Annex 16 to the EU Guide to Good Manufacturing Practice:
“8.3 A QP should maintain his knowledge and experience up to date in the light of technical and scientific process and changes in quality management relevant to the products which he is required to certify”.
The RSC provides an online tool to help you record your CPD, www.rsc.org/cpd, or follow the link from the QP pages at www.rsc.org/qp. As an alternative, you can use this CPD for QPs form and return it by email or post.
How much and what types of CPD activities do I record?
The key to successful career planning is realistic self-analysis.
Identify the areas where development is needed.
Identify any specific requirements for a new role or tasks that have changed.
How do you ensure that your knowledge remains up-to-date?
Do you need to develop new skills?
The CPD record will be assessed by the RSC against the self-analysis identified and recorded by you on the summary form. Registrants are requested to complete the CPD records by recording evidence of competencies during the review period (e.g. one year) and submitting the summary to the RSC. You may wish to use, as a starting point, the key knowledge and experience for QPs as defined within the QP Study Guide. This is available on the RSC website at www.rsc.org/qp, and there is a summary of the Study Guide elements in the Appendix to this document.
How will my CPD be assessed?
You will be invited periodically to submit a summary of your CPD record to the RSC. The RSC will consider your summary of activities to determine whether you have demonstrated that you are keeping your knowledge and skills up to date.
Using the RSC CPD framework is voluntary, but if you send an appropriate return, the date will be noted in the QP Register.
New registrants will receive guidance on CPD on acceptance to the register.
Specialist Skills QP 2013 page 2
Specialist Skills QP 2013 page 3
Summary Record-Sheet of CPD for QPs
Also available as a word file on the RSC website at www.rsc.org/qp
Please refer to the Guidance notes for CPD for Eligible Qualified Persons before completing the summary.
Period covered by summary From To
1. Personal details
Name:
Membership number:
Category of membership:
2. Address and employment
Enter the details you wish to be shown in the Register:
Address:
Email address:
Telephone: Fax:
Website address :
Please tick the box if you wish your entry to appear on the website
Specialist Skills QP 2013 page 4
3. Professional experienceList your key responsibilities and describe the range of products to which these responsibilities relate, e.g. sterile liquids, tablets, capsules etc, during your CPD assessments period.
Job title and employer Dates Duties
From: To:
4. QP activity
Are you named as a QP on a Manufacturer’s licence?
yes no
Are you actively releasing product?
yes no
Specialist Skills QP 2013 page 5
5. Self-analysis
List your career ambitions and aspirations during the CPD period.
6. Skills Development
List your skills development required to achieve your ambitions and aspirations.
1.
2.
3.
4.
5.
Continue on a separate sheet if necessary.
Specialist Skills QP 2013 page 6
7. Progress to date
List your progress to date.
1.
2.
3.
4.
5.
8. Certification by applicant
I certify that the information given on this CPD summary is correct to the best of knowledge and belief.
Signature ____________________________ Date:
Please return the completed Summary Record Sheet to:
Registration OfficerRoyal Society of ChemistryThomas Graham HouseScience ParkMilton RoadCambridgeCB4 0WF
Telephone: 01223 432690Email: [email protected] www.rsc.org
CPD Records page 7
Appendix: Study Guide elements
Foundation knowledge elements
a. Pharmaceutical law and administration
Work-place experience
Other development activities
b. The role and professional duties of a Qualified Person
Work-place experience
Other development activities
c. Quality management systems
Work-place experience
Other development activities
Additional knowledge elements
d. Mathematics and statistics
Work-place experience
Other development
CPD Records page 8
activities
e. Medicinal chemistry and therapeutics
Work-place experience
Other development activities
f. Pharmaceutical formulation and processing
Work-place experience
Other development activities
g. Pharmaceutical microbiology
Work-place experience
Other development activities
h. Analysis and testing
Work-place experience
Other development activities
CPD Records page 9
i. Pharmaceutical packaging
Work-place experience
Other development activities
j. Active pharmaceutical ingredients
Work-place experience
Other development activities
k. Investigational medicinal products
Work-place experience
Other development activities