Title / Position: AuditorE-mail Address:slc.mbonett@gmail.comTelephone: +35699774545Website URL:Social Media Profiles:https://www.linkedin.com/in/michael-bonett-4022212/Location:ItalyLanguages spoken: English, Italian, Dutch, MalteseGeographic Areas Covered: EuropeName of Firm: Straight Line ConsultantsNo. of Practising Consultants: 1
Educational / Professional BackgroundAcademic Qualifications (degrees, diplomas, etc.)Qualified Pharmacist. Certifications and Accreditations relating to Pharmaceutical Good Distribution Practice (GDP)IRCA Registered Pharma Auditor.Membership of relevant professional organizations or associationsRQA, CQI, ASQ, IPSE, PDA, GDP-UCI.Involvement in GDP-UCIFounding member
Professional Skills, Experience and ExpertiseNo of years of experience in Pharmaceutical Good Distribution Practice (GDP)23 Previous Companies worked for in the Pharmaceutical IndustryJohnson & Johnson, UPS, Baxter, Boehringer Ingelheim.Specific areas of specialism or particular experienceAuditing, QA consultancy, remediations deviations and CAPA risk assessment.Familiarity with Specific Regulatory Frameworks and GuidelinesEU; USA Relevant Training or Courses AttendedHealth Canada, US FDA Software or Technical Skills related to Pharmaceutical Supply Chain ManagementIT literate with Veeva Trackwise training and documentation system
GDP CONSULTANTS
Client Testimonials / ReferencesProfessional referencesAvailable on request and refer to LinkedIn Profile (link above) References or links to case studies / past projectsSetting up Warehouses And Acquisitions for UPS Healthcare in Europe for 5 years
Other InformationReview of the new GDP draft and comments sent to the EU to revise the first draft regarding transportation hubs.Available for independent audits and QA work.
In their own words:
“Certified GxP QA consultant with 25 years of experience and a registered auditor that performed over 100 audits and maintained responsibility for 25 warehouse licenses and 10 GMP packaging/labelling areas”
Good Distribution Practice - Universal Compliance Initiative