Hans (J.P.) De Koning Email & Phone Number

Hoofddorp

Project management and consultancy services related to GMP compliance.* Writing Contamination Control Strategy* Risk assessment Cross Contamination* Gap assessment EU-GMP Annex 1 (2022)* Writing QMS Policy documents* Project manager qualification and validation BSL-3 laboratory* Commissioning and qualfication of clean utilities (Cold WFI, CCA, N2)* Project manager Technology Transfer production relocation of multiple aseptic products* Project manager commissioning and qualification for new pharmaceutical facility* Writing C&Q documentation for new filling line for oral liquids * Quickscan License to Operate * Auditing * Initiation of validation project for medication dispensing systems* Supporting QA department (PQR review) * (a.i.) QA Manager * Validation team lead (Start-up Validation department) * Project manager for Installation / qualification of decontamination autoclave at BSL-3 facility

Hoofddorp

Bestuursvertegenwoordiger van de DARQA GMP commissie

Hoofddorp

Amsterdam-Duivendrecht

Responsible for all QA activities within the company.- Maintaining Quality Systems- Sponsor batch release to clinical studies

Leiden

Responsible for:- Change Control System, - QA responsibility for validation activities, - GMP Training System- LIMS Application Management- Management ReviewThe various experiences include: - QA representative in various construction, renovation and CMO projects * installation and qualification of an industrial freeze dryer * qualification of a BSL2 facility- (Internal) auditing, - Management experience as a QA manager as well as management of QA activities within project teams.

Leiden

Create and implement Validation Master Plan of HAL Allergy.Within construction team QA responsible for the validation activities related to the construction of the new GMP facility of HAL Allergy in Leiden. (Opening July 2009)Implementation of Change Control System.QA responsibility for validation activities.Improvement of GMP Quality Systems.

Leiden

Project management and consultancy services related to GMP compliance. - Various projects for pharmaceutical companies in the field of validation and GMP compliance. - Preparation and implementation of SOPs, VMP's, protocols and reports for equipment validation, analytical methods, cleaning validation and (retrospective) process / product validations (incl. vaccine manufacturing).Instructor at internal courses of Univalid:- Pharmaceutical Water and Steam- Presentation training

Groningen

‘Development of a dry powder inhaler for inhalation therapy with antibiotics in Cystic Fibrosis’- Co-operation project between the Leyenburg Hospital, The Hague, Department of Pharmaceutical Technology and Biopharmacy of the University of Groningen and an industrial partner.Teacher for various courses within the Pharmacist degree education.

Phd, Pharmaceutical Technology And Biopharmacy

Dissertation titled: "Dry Powder Inhalation: Technical and Physiological aspects, Prescribing and Use." 7 mei 2001. Department.

Prince2 Foundation

Leergang Professioneel Leiderschap (Professional Leadership)

Quality Management In Pharma And Biotech

Biopartner Masterclass Biobusiness 2002

M.Sc, Pharmacochemistry

Vwo