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Service Provider Life Cycle Management - Essential Steps to Achieving Quality and Compliance

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Face-to-face Course

Course Information

This course helps you understand the rules and standards for managing Vendors used in GCP and GPV environment. You will learn practical ways to manage service providers and find what works best for your organisation. The course offers a clear method to assess vendor risk, maintain correct  documentation, such as contracts and vendor management plans, and ensure vendors follow both internal and external requirements. Build and develop partnerships between service providers and Sponsors/Marketing Authorisation Holders (MAH)

Who should attend?

This course is designed for professionals involved in vendor management and compliance.  If you hold any of the following roles, you will benefit from this course:

  • Operational staff directly responsible for service provider management (e.g., Project Managers, Vendor Managers, Study Team Managers)
  • Line managers overseeing vendor management roles
  • QA staff responsible for assessing vendor performance and compliance
  • Procurement staff involved in selecting and managing service providers

Course objectives

  • Regulatory Compliance: Develop a clear understanding of the regulatory frameworks governing vendor management and learn how to apply them in daily operations.
  • Service Provider Selection: Gain the ability to evaluate and select vendors that meet your organisation’s specific needs while ensuring alignment with both business goals and compliance requirements.
  • Risk Assessment: Learn how to conduct thorough risk assessments for vendors, identifying potential issues and developing tailored risk mitigation strategies to safeguard your organisation.
  • Service Provider Oversight and Governance: Master the techniques for establishing effective vendor governance, including monitoring performance through key indicators and addressing quality issues in a structured manner.

 By the end of the course delegates will be able to:

  • Understand regulatory requirements and expectations for vendor management and oversight
  • Learn how to identify and select service providers that fit your company’s needs
  • Gain skills in assessing vendor risks and developing strategies to manage them
  • Explore best practices for vendor governance, including setting key performance indicators and managing quality issues

Tutors

Tutors will be comprised of (click the photos for biographies):

Michael Ramcharan

Michael Ramcharan

Director, Reumat Consulting Ltd

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Michael Ramcharan

Michael Ramcharan (Reumat Consulting Ltd) has over 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations (CRO) mainly in the GCP and GPV areas. He has conducted a wide variety of audits (both On-site and Remote) globally, and managed various risk-based audit programmes. He has also hosted and supported many European Regulatory Authority Inspections (eg; MHRA, EMA, Local EU country Inspectorates).

Michael’s audit experience has also extended to designing and implementing various audit and Training programmes, providing Training on a variety of GCP and GPV topics, and for providing general Quality Management System (QMS) support.

He is currently a member of Research Quality Assurance (RQA), and a committee member of the RQA Wales & South-West, UK Regional group, and the current Programme Committee Chair for the RQA Brighton 29024 conference.

Maria Veleva

Maria Veleva

Director, Velev Consulting Ltd

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Maria Veleva

An open-minded, courageous, and detail-oriented scientist, Maria Veleva brings over 20 years of clinical research experience and is recognised for delivering effective, fit-for-purpose quality solutions in the life sciences industry. With a creative approach to problem-solving and a deep commitment to improving patient outcomes, Maria has consistently demonstrated the ability to design and lead innovative quality initiatives that significantly enhance operations across multiple organisations.

As the Founder and Managing Director of Velev Consulting Ltd., Maria partners with biotech and pharmaceutical companies, CROs, and clinical service providers to enhance efficiency, improve process quality, and mitigate risks in clinical trials. Her expertise in GCP audits, inspection readiness, QMS, and quality gap analysis has made her a trusted advisor in the industry.

Before founding her consultancy, Maria held several leadership positions at IQVIA, including Quality Management Sub-Regional Head for Europe. In this role, she developed and implemented successful quality strategies, drove the adoption of a quality culture across the organisation, and contributed to the development and management of company SOPs, process improvement initiatives, and audit and inspection preparation and response.

Maria is a certified Lean Six Sigma professional and a sought-after trainer and speaker, having presented at numerous international conferences and authored several publications on topics related to clinical research and quality management.

Programme

Please note timings may be subject to alteration.

Day 1

10:00

Introductions & Course Overview

10:15

Background/Regulatory expectations

GCP and GPV requirements Terminology Outsourcing strategy and tips

10:45

Identification of Vendors

Business needs and Expectations Considerations and Challenges Type of Relationship

11:15

Break

11:30

Vendor Selection

Qualification Process Criteria to assess Risks "Can they do what they say"

12:15

Lunch

13:00

Vendor Management

Contracts Performance Monitoring (Key Metrics and KPIs) Data Integrity Vendor Training

13:45

Audit and Inspection Observations

Analysis and discussion of Inspection Findings

14:30

Break

14:45

Exercise

Put into practice the learning during the day based on a given scenario

15:45

Closing Remarks

16:00

Close of Course

Extra Information

Course material

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per course.

The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.

Development Level

All

Book now

Click below for Course dates/fees:

Face-to-face Course
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