1. Quality
Matters
Getting it right…..
- Thinking of
Patients
- Collaborating with
Investigators
- Supporting Clinical
Operations teams
- Understanding GxP
challenges
- Effective audit and
inspection
- Dialogue with
Regulators
- Cost effective
dispensary services
…….…talk to us
Quality
Matters
Practical, experienced-based
solutions to quality and GxP
challenges.
2. Experience
Over 25 years at senior level in Quality
Management, Product Development & NHS
roles. Experience in global pharmaceutical
companies, start-up ventures, IMP supply
chain activities, and patient facing roles.
Specific experience includes:
Implementing a quality management
system (QMS) from “nothing” through to
successful MHRA GCP audit
Director of a European based IMP packing
& labelling team, with a proven track
record of delivery, meeting quality
standards, successful outsourcing &
teamwork
Management & leadership of major
change initiatives, including operational
effectiveness & “in-out” decision making
NHS Practice Pharmacist in a city centre
& rural dispensing Dr surgery
“the QMS was pitched just right for our
organization, including the cultural
changes needed to make it
successful”…..former CEO e-Therapeutics
“Calm and focused during the MHRA
inspection”…external auditor
“Jane transformed the Dispensary into an
efficient, patient focused, cost effective
operation”……..GP, Huntingdon Road
Surgery, Cambridge
Services
Establishing, implementing and review of
quality systems
Writing & implementing policies, guidelines &
standard operating procedures (SOPs)
Mentoring, coaching & oversight for
inexperienced GxP staff
Managing and assessing suppliers
Input to due diligence activities
An invaluable, occasional assistant for busy,
senior Quality Managers
GxP training (GCP, GMP, GDP)
Support for audit & inspection
Advice on Controlled Drug licensing & audit
Review of Dispensing Dr services, training &
appraisal of Dispensary staff
About me
Since 2012, I’ve worked with my husband,
Steve Self, to establish Morden Pharma
Consulting, providing a pharmaceutical
consultancy service. Between us we have
over 50 years of experience in the industry
and the NHS! We also have a well-
established network of associates who can
often help if we can’t.
I’ve worked as a Director in large global
pharma companies, as a member of a small
teams (just me part-time in the Quality
Department!), as part of the NHS (I’m a
registered Pharmacist) and as a Consultant
– always striving to build effective working
relationships & achieve business objectives.
I’m motivated by finding pragmatic
solutions to overcome issues and working to
high standards with impact & influence in all
areas of compliance
I have a breadth of experience that may
help you solve a problem, please give me a
call or email.
Contact
Morden Pharma Consulting
Lower Ward Farm
Yarnscombe
EX31 3LU
Telephone: 01769 560820
Mobile: 07803121391
Email: janeself@mordenpharma.com