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Capabilities

Experience

Conducting Audits (GMP en ISO) o Internal audits (300+ performed) o Supplier audits (400+ performed) o MOCK Inspections (IGZ, FDA, PAI, FAGG) Audits are conducted according to ISO 19011 and/or specific needs Preparation for and/or hosting of audits and inspections GMP review of Qualification/Validation documents GMP review of Procedures and Work Instructions GMP review of batch and packaging documentation Setting up (parts of) quality systems Developing and executing GMP training e.g. o Internal Audits o ‘Omgang met inspecties’, how to undergo an inspection o GMP Awareness Expert in RadioPharmaceutical GMPs

Extensive knowledge and experience in practical use of the following

guidelines:

21 CFR 210, 211, 212, 820, ISO 9001, 13485 Eudralex Volume 4, parts 1, 2, 3 and all annexes ICH guidelines Q 7, 8, 9, 10 Korean GMP Japanese GMP ISPE Guidelines

Did you know De Jong Pharma Consult works for 6 out of the 10 largest

pharmaceutical companies of 2016? Click here for the top 10

Welcome

De Jong Pharma Consult is your independant solution for all your quality related questions. Whether you need to have your suppliers audited, a quality system build or your staff trained. De Jong Pharma Consult is the answer to all your questions.

Curriculum Vitae

A complete and extensive CV is available, just contact us.
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