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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.
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

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Morden pharma consulting quality services v01 a4

  • 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