GMP4Pharma® is a Danish based independent training, auditing, and consultancy company in the area of pharmaceutical drugs and medical devices owned by Per H. Damgaard. The company is based on 25 years of experience from working with Quality Control, Quality Assurance, Audits and Inspections.
GMP4Pharma® was incorporated in 2010 by Per H. Damgaard. From 2010 to 2022 the company expanded from performing a few in-house and open courses a couple of time a year to a more extensive training catalogue while at the same time having a full-time job at Novo Nordisk A/S.
As of March 1, 2022, GMP4Pharma® became my full-time employment focused on giving training and performing audits to the business of pharma and medical devices.
From March 1, 2024, GMP4Pharma® became an affiliate of the worldwide Epista Life Science Group together with Genau&More.
We specialize in the development and presentation of courses associated with the good manufacturing compliance requirements for the pharmaceutical and active pharmaceutical ingredients industries. Our GMP compliance and training programs are meticulously selected to fulfill training and education requirements that promote drug product quality and GMP compliance.
The objective of our training programs is practical and current application. Program selection and course contents are usually determined based on industry surveys which show that no similar programs, or programs with the same level of quality, are being offered by other industry organizations.
Our most popular course is the annual GMP up-date course. It is a regulatory requirement that training be given in GMP/GDP, and the regulatory expectation is that this is performed at least once a year.
GMP4Pharma® also customizes and presents these courses and programs on-site at the client’s premise. Having performed courses on-site or remotely for all major drug companies in Denmark as well as open courses in Japan and China, the experience with training and training development is large.
All trainings are done in collaboration with Genau&More. For more information see Affiliates.
We specialize in performing audits within GMP, GDP and ISO 13485/MDSAP. Having performed +100 audits within Drug substance/Drug Product/Medical Devices as both internal auditor as well as supplier auditor, the experience is substantial. The audits have been done on six continents and we therefore possess the skills of handling audits within many different cultures. In addition, we have been hosting inspections from various medical authorities around the world including DKMA, US-FDA, ANVISA and many more, and thereby we have an in-depth knowledge of the authority expectations when it comes to all elements of the QMS.
Please reach out to us. We have experience in performing audits both remotely and on-site – Audits, Where you need it – When you need it
Training have been performed at various auditor training courses to enhance the auditing skills of new as well as experienced auditors, and these being done as both in-house and public courses.
Due to the extensive experience in hosting both GMP inspections from national competent authorities like US-FDA, both PLI/PAI and routine inspections, as well as authorities from Denmark, Russia, Turkey, China, Brazil, we offer support in connection with authority inspections – before, during and after the inspection.
Per H. Damgaard is a PhD in microbiology from the former Royal Veterinary and Agriculture University of Copenhagen (now University of Copenhagen). During his studies he spend time at Washington State University (Pullman, USA), National Research Council (Ottawa, Canada) and DLO Research and Institutes (Wageningen, Holland). Before leaving the world of academia he was employed as Assistant Research Professor at RVAU.
Dr. Damgaard has more than 25 years of experience from the pharmaceutical industry where he has worked in both managerial (Vice President, Director and Department Manger) as well as subject matter expert positions. He has experience from both Drug Substance as well as Drug Product manufacturing, from both QA and QC, as well as a GMP auditor in both drugs and medical devices.
GMP4Pharma® is an affiliate of the Epista Life Science Group together with Genau&More. Together we offer a range of training to the life science community within GMP and GDP.
Our open courses will be posted shortly at the link below. Are you in need of a customized GMP course to fit your needs in QA, QC, production, please reach out to us using the Contact form. We cover everything from Annex 1 in sterile manufacturing to API production, from Root Cause Analysis to Computer Systems Validation.
Please use below form for any inquiries about courses you would like to have and we will call you to discuss the details of the course and ensure that you will receive a high quality offer.
GMP4Pharma® • Lyngknuden 18 • DK-4400 Kalundborg • Denmark
+45 5011 5022 • info@gmp4pharma.com