GCP Auditing and

Quality Services


KEY TO QUALITY

KEY TO COMPLIANCE

KEY TO SUCCESSFUL FILING

KEY TO PEOPLE DEVELOPMENT


About "KEYGCP Services"



After 25+ fantastic years serving in Pharma Industry and at a CRO within GCP Quality, Compliance, and Clinical Operations, it was time to continue my growth and leverage all my expertise by helping other Bio-Pharma companies, CRO's and Health Care Organizations.

 

KEYGCP services is specialized in GCP Auditing & Quality services and was founded in December 2022.


Key deliverables:

Enhancing Quality and Compliance of Clinical Trials within your organization through auditing, risk-based audit strategy and planning.


Advising on key GCP deliverables in the drug development process, through document review and identifying areas of risk.


Consulting on GCP/QA challenges and needs.


Coaching and training of Quality, Compliance and Clinical Operations staff in auditing and CAPA management.

Services list

(non-exhaustive)


  • Worldwide freelance consultancy support in clinical trial (Phase I-IV) audit activities from risk-based audit scheduling to audit planning and audit execution; i.e. investigator site-, vendor- and internal system audits.
  • Inspection readiness and inspection management activities to ensure timely and successful filing; mock inspections, training and coaching, document & file review.
  • All-round quality management, GCP consulting, CAPA expert, keen to work on quality culture optimization projects and support your quality management system (QMS).
  • Training and coaching of quality, compliance and operational teams allowing future career opportunities and to support compliance with regulations.


                     About me


Ilse Nelissen

Consultant - Founder of KEYGCP Services

ANNIE

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LAURA

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An experienced leader in GCP Quality, Compliance, Training and Clinical Operations for >25 years within the Pharma Industry and at/with CROs.


Patients, People and Science have always been my passion and have been driving my career path to where I am today.

I truly enjoy auditing and managing key Health Authority inspections across therapeutic areas at sponsor-, investigator site-, as well as vendor locations across the globe.

Managing and leading teams (directly and indirectly) throughout these activities while training, coaching them along the way has been a natural and fulfilling task.

Another rewarding and enriching opportunity in my career was to hire, train and lead GC(L)P auditors in China and Belgium while building the AsiaPac Clinical Trial Strategy with the Key Stakeholders.


Applying risk-based and end-to-end thinking during the approximately 200 audits and inspections I performed and managed resulted in many Research and Development and Quality Assurance process improvements.

I am a loyal, results driven, hardworking leader while always curious and open for challenges, leading me to the ultimate challenge of starting-up my own company.

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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