Title / Position: Pharmaceutical GDP Consultant RP/RPi E-mail Address: Telephone: +447803292999 Website URL: N/A Social Media Profiles: pharma-ltd Location: United Kingdom Languages spoken: English Geographic Areas Covered: UK; EU; USA Name of Firm: Christa GDP Pharma Ltd No. of Practising Consultants: 1
Educational / Professional Background Academic Qualifications (degrees, diplomas, etc.) Certifications and Accreditations relating to Pharmaceutical Good Distribution Practice (GDP) Cogent Gold Standard Responsible Person certification. Lead Auditor qualification from Lloyds Registered Quality Assurance. Membership of relevant professional organizations or associations CQI PQG; GDP-UCI. Involvement in GDP-UCI Member of Audit & Certification Primary Workgroup. Member of Guidancs & Solutions Primary WorkGroup. Deputy Team Lead - GDP Knowledge Bank WorkGroup.
Professional Skills, Experience and Expertise No of years of experience in Pharmaceutical Good Distribution Practice (GDP) 16 Previous Companies worked for in the Pharmaceutical Industry Yusen Healthcare Logistics; Movianto Healthcare Logistics; Carelide UK Ltd; AFT Pharma (NZ). Specific areas of specialism or particular experience Expertise in GDP auditing, QMS building, writing GDP-related procedures, and developing Quality Technical Agreements. Familiarity with Specific Regulatory Frameworks and Guidelines In-depth knowledge of EU GDP guidelines, Home Office Controlled Drugs guidance, Human Medicines Regulations 2012, WHO guidance, ICH Q9, ICH Q10, and intermediate knowledge of ICH E6. Relevant Training or Courses Attended Software or Technical Skills related to Pharmaceutical Supply Chain Management Extensive experience in inventory management systems, QMS software, data analytics, reporting tools, ERP systems, and RFID/Barcode technology.
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Client Testimonials / References Professional references Available on request. References or links to case studies / past projects 1.Lead contributor for GSK in developing new GDP guidelines for medicinal product distribution across Europe in 2013. 2. Senior lead overseeing a European-wide temperature mapping program for GSK's road freight operations involving 60 different EU carriers in 2015. 3. Authoring global shipping protocols and standards for temperature-controlled distribution for AstraZeneca in 2019.
Other Information Active participation in MHRA Symposiums since 2015; Speaker at SeerPharma GDP Symposium 2022; Speaker at Distributing Pharma Conf. 2023; Delivery of webinar on auditing for Qualistery. I aim to increase awareness of GDP, stressing the crucial need for minimum compliance standards in the entire supply chain. My focus is on promoting stakeholder understanding of patient safety and driving continuous improvement.

In their own words:

“A seasoned Pharmaceutical GDP veteran, ready to help with your compliance! From audits and training to risk assessments and mock inspections, delivering comprehensive solutions, regulatory compliance, and optimising operations and supply chain efficiency”
Good Distribution Practice - Universal Compliance Initiative


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