Title / Position: Contract Auditor GMP/GDP ISO 9001:2015; Trainer E-mail Address: Telephone: +995595904750 Website URL: N/A Social Media Profiles: gabisiani-a4788186 Location: Georgia Languages spoken: Georgian, English, Russian Geographic Areas Covered: Eastern Europe, EU, Central Asia Name of Firm: Freelance No. of Practising Consultants: 1
Educational / Professional Background Academic Qualifications (degrees, diplomas, etc.) Master's Degree in Pharmacy, PhD Biochemistry Certifications and Accreditations relating to Pharmaceutical Good Distribution Practice (GDP) Examination Certificate: 3 modules Training of Pharmaceutical Inspectors with Reference to EU-GMP Legislation, GMP/GDP Inspector/ Pharmakon, Danish College of Pharmacy Practice CQI IRCA Certified ISO9001:2015 Lead Auditor (Quality Management Systems) course (cert. N 6154946) Membership of relevant professional organizations or associations IRCA Georgian National Academy of Sciences / GNAS; GDP-UCI. Involvement in GDP-UCI Member of Audit & Certification Primary Workgroup.
Professional Skills, Experience and Expertise No of years of experience in Pharmaceutical Good Distribution Practice (GDP) 5 Previous Companies worked for in the Pharmaceutical Industry Ministry of Labor, Health and Social Affairs of Georgia/ LEPL Regulation Agency of the Medical and Pharmaceutical Activity GMP/GDP Inspector. Specific areas of specialism or particular experience Auditing, QMS development, Licence applications, training, GAP Analysis, CAPA development/Verification. Familiarity with Specific Regulatory Frameworks and Guidelines EU GMP/GDP, WHO, ICH, PIC/S, ISO. Relevant Training or Courses Attended Refer to CV available on request. Software or Technical Skills related to Pharmaceutical Supply Chain Management Quality Auditor skills.
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
Client Testimonials / References Professional references Available on request. References or links to case studies / past projects GMP/GDP Regulatory Audits, 3rd-party GDP Audits, Individual projects for Wholesale Distributors and Brokers, Standard Compliance/QMS development, Personnel Training, GAP analysis, CAPA implementation; All client companies have reached the final goal of meeting regulatory compliance.
Other Information Involvement in the harmonization process working group for pharmaceuticals within Georgian legislation Conducting a market assessment study for the Georgian pharmaceutical market prior to adopting EU standards, and developing a roadmap for the transitional period to harmonize legislation. QMS development for the Regulatory Inspectorate.

In their own words:

“A dedicated Quality Assurance Specialist, I am committed to supporting your GDP-related activities, ensuring the integrity of pharmaceutical products across the supply chain. Audits and quality improvement activities provide individually tailored roadmaps for improving standard compliance''
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