KHATUNA GABISIANI
Title / Position: Contract Auditor GMP/GDP ISO 9001:2015; Trainer E-mail Address: kh.gabisiani@gmail.com Telephone: +995595904750 Website URL: N/A Social Media Profiles: linkedin.com/in/khatuna- 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.
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''
GDP CONSULTANTS
