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Wladyslaw Kalin, MsC
Senior GCP Auditor, Germany

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  • LinkedIn

  • 20 years of clinical trial industry experience in multinational CROs, including:

  • 13 years with clinical Quality Assurance (consulting, planning and conducting various types of internal, and contracted audits, QMS support and process improvement, oversight of RA inspections, functional management of auditors)

  • 7 years with Clinical Operations (monitoring and management of clinical trial sites

Specialties

  • Quality Risk Management & Quality by Design

  • Process analysis and re-engineering in Clinical Trial Management and Monitoring

  • SOP Development & Management  

  • GCP Audits and Issue Management

  • Regulatory Intelligence for Compliance 

  • Regulatory Inspections support

Experience
​Major multinational Clinical Research Organizations (HQ /US & Ireland):

  • Development and implementation of internal audit strategy, concept, methodology, and relevant processes

  • QMS support by identification of risks and areas for improvement, GAP analysis, audits planning and conduct, development of QMS documents, and review for compliance with GxP guidelines and applicable regulations

  • Coordination, oversight, and support of GCP inspections conducted by Regulatory Authorities at CRO’s or Sponsor’s premises and Investigator Sites in Europe, Africa, and the Asia-Pacific region.

  • Functional management of a team of QA Auditors in Europe

  • Planning, conducting, and following up on GCP, GDP, and GCLP audits of the Trial Sites, CROs, and third-party vendors involved in clinical trials

  • Providing consultancy services in the field of GxP guidelines and regulatory compliance.

  • Evaluation and management of quality issues and site-specific escalations related to persistent or serious misconduct

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Major multinational pharmaceutical and small biotech companies (as part of contracted CRO services):

  • Support to the clients’ global audit programs

  • Conduct site and third-party vendor audits

  • Projects’ inspection readiness assessments

  • Auditing project deliverables (such as Trial Master Files, Clinical Study Reports, and Databases)  

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Training Activities:

  • Training and coaching of new staff in the Quality Assurance department

  • Specialized in-house or remote training on GxP guidelines and relevant company processes

  • Specialized pre-inspection training dedicated to the CRO staff and Investigators in charge of preparing and hosting Regulatory Authority inspections

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