GCP Auditing and

Quality Services


KEY TO QUALITY

KEY TO COMPLIANCE

KEY TO SUCCESSFUL FILING

KEY TO PEOPLE DEVELOPMENT


About "KEYGCP Services"


Welcome to KEYGCP Services!


As a professional Quality consultant, I am committed to sharing my extensive experience with Biotech-, Pharma- and Healthcare organisations.


Founded in December 2022, KEYGCP Services specializes in offering customized GXP Auditing & Quality services to meet your organization's specific requirements.

By utilizing my services, your organization can experience:


  • Improved Quality and Compliance of Clinical Trials through risk-based auditing.

  • Strategic planning and execution of GXP audits, including support in selecting qualified external auditors.

  • In-depth insights into vital GCP aspects of the drug development process by examining documents and identifying key focus areas.

  • Preparation for inspections, as well as management of pre-inspection and on-site inspection visits.

  • Expert consultancy to tackle GCP/QA challenges and meet requirements.

  • Training and mentoring for Quality, Compliance, and Clinical Operations teams to support audit related processes and CAPA management.


                     About me


Ilse Nelissen

Consultant - Founder of KEYGCP Services

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With over 25 years of experience in GCP Quality, Compliance, Training, and Clinical Operations in both large and small biopharmaceutical and biotech companies, as well as CROs, I have gained expertise in leading teams and managing key Health Authority inspections globally.


Driven by a passion for Patients, People, and Science, my career journey has focused on delivering excellence in auditing and overseeing inspections at sponsor-, investigator-, and vendor sites located worldwide.

I enjoyed the mentoring and coaching of teams during these critical activities, fostering growth while achieving objectives both directly and indirectly.


An enriching chapter in my career involved recruiting, training, and supervising GC(L)P auditors in China and Belgium, while collaborating with key stakeholders to develop the Asia Pacific Clinical Trial Strategy.


My approach, guided by risk-based thinking, was instrumental in executing approximately 200 audits and inspections, leading to significant enhancements in R&D and Quality Assurance processes.


During my consultancy tenure at a small biotech pharma company, I broadened my skill set by managing "GXP" audit activities; establishing the annual GXP audit plan, appointing qualified external auditors and coordinating all GXP audits seamlessly.


As a dedicated and results-oriented professional, I thrive on tackling challenges, embracing continuous learning, and sharing my wealth of knowledge and experience with others.

Testimonials

Kristel Van de Voorde

Vice President Clinical Trial System and auditing QA at BMS


llse can coordinate complex projects and engage stakeholders across departments to make the project successful. She successfully led the entire audit program globally for one of our major compounds across indications and regions. This program also involved a partnership with an alliance partner and was outsourced, which required skillful communication and relationship building.

Patricia Dewaele

Director Global Quality Clinical Trial Systems and Auditing at BMS

As an auditor, Ilse has the capacity to see issues from a helicopter view, connecting the dots beyond departmental boundaries. She is able to identify the gaps in the process, but also in advising potential action plans to remediate the issue. She led key EMA inspections to successful outcome, because of her ability to approach complex issues in a systematic and organized manner, involving the right stakeholders at the right time.

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