RICHARD COE
Title / Position: RP/RPi, GMDP lead auditor, QMS remediator E-mail Address: richard@protogenconsulting.co.uk Telephone: +447779619378 Website URL: Social Media Profiles: https://www.linkedin.com/in/gdpdirector/ Location: UK Languages spoken: English Geographic Areas Covered: UK, Ireland, EU Name of Firm: Protogen Consulting Ltd. No. of Practising Consultants: 1
Educational / Professional Background:
Academic Qualifications (degrees, diplomas, etc.)
B.Mech.Eng.
Certifications and Accreditations relating to
Pharmaceutical Good Distribution Practice (GDP)
IRCA Certified GMDP Lead Auditor RP / RPi (MHRA Reg No:15741276)
Membership of relevant professional organizations or
associations
C.Eng.; IMechE MCQI; Chartered Quality Institute; GDP-UCI.
Involvement in GDP-UCI
Knowledge Bank Moderator; Member of Audit & Certification
Primary Workgroup; Member of Guidance & Solutions Primary
Workgroup.
Professional Skills, Experience and Expertise
No of years of experience in Pharmaceutical Good
Distribution Practice (GDP)
27
Previous Companies worked for in the Pharmaceutical
Industry:
Long term (>6mths) contracts: GSK Belgium, RVI Pharmacy
Manufacturing Unit, Newcastle. Patheon, Swindon. Lonza Biologics,
Slough. Novartis Vaccines, Italy. Xellia Pharmaceuticals, Denmark.
Agility Logistics, UK and Ireland. Paradigm Shift Consulting. UK. Alm
Pharm Ltd., UK. Manx Healthcare Ltd., UK.
Specific areas of specialism or particular experience
Quality risk management. Equipment, systems, facility, process
validation. GDP QMS new, remediation and training. Practicing RP
and RPi.
Familiarity with Specific Regulatory Frameworks and
Guidelines
EU GDP and GMP (as set out in green and orange guides) MHRA
guidances WHO Technical Reports ISPE baseline guides GAMP 5.
Relevant Training or Courses Attended
ISO 9001 Lead Auditor IRCA accredited GMPD Lead Auditor (Inspired
Pharma) Responsible Person and Responsible Person (import) (Seer
Pharma) Annual CPD e.g. MHRA Symposia. Regular GDP refreshers
(https://gdptraining.co.uk/)
Software or Technical Skills related to Pharmaceutical
Supply Chain Management
Systems in manufacture and distribution. Computer / control
systems and validation.
Client Testimonials / References:
Professional references
Available on request
References or links to case studies / past projects
Available on request
Other Information
Implementation and training of GDP QMS after publication of
2013/C 343/01 Guidelines of 5 November 2013 for Xellia
Pharmaceuticals initially at its Copenhagen, Denmark site,
subsequently rolled out to Budapest, Zagreb, Taizhou (China) and
Raleigh (North Carolina) sites. Design risk assessments, QMS,
compliance and successful initial WDA inspections for warehouse
operations at Agility Logistics Heathrow, Alm Pharm UK Ltd., Manx
Healthcare Ltd.
Regular contributor on quality risk management at GDP and
logistics conferences.
Contact me for a free no-obligation assessment to establish your
requirements.
In their own words:
“A pragmatic and resourceful GMDP specialist ready to help with your compliance requirements. Focussed on “right-first- time” facility / process design ensuring inspection success and optimising operational / supply chain efficiency”
Good Distribution Practice - Universal Compliance Initiative
GDP CONSULTANTS
