Title / Position: RP/RPi, GMDP lead auditor, QMS remediator E-mail Address: Telephone: +447779619378 Website URL: Social Media Profiles: 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 ( 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
Contact us +44 (0)207 096 9119 By-the-industry, for-the -industry:  a member-driven GDP initiative  Contact us By-the-industry, for-the-industry:  a member-driven GDP initiative
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


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