News

The GMP experts invites university graduates to meet and get to know each other in order to provide information about starting a career in pharmaceutical quality assurance and the working world of GMP.

...

Distributors and importers of medical devices have a lot to be prepared for with the EU MDR. What reporting requirements have been defined? What does this mean in concrete terms? How can this be implemented?

...

What ist new for Combination Products? -- Changed approval process, additional control in life cycle -- Regulatory Affairs -- New technical article from gempex

...

The periodical inspection of compliance is a central requirement of the GxP regulations. At PharmaTechnica, Dr. Ralf Aubeck reports on the importance of inspection readiness for pharmaceutical manufacturers and how to face US FDA audits calmly.

...

A Stable QM System With Clear, Efficient Processes was Realized. QM System Upgrade, Inspection Readiness, Training and long-term GDP Compliance Consulting

...

Increasing requirements for pharmaceutical production also concern the partners in the entire distribution chain. Well-known speakers from the GDP scene will explain how the major challenges can be managed at Concept Heidelberg's live online seminar on March...

...

Great savings potential for internationally operating medical device companies -- - Harmonized QMS certification for medical device manufacturers in the export markets AUS, BRA, CAN, JAP, USA -- lean and efficient

...

CureVac is a biopharmaceutical company pioneering the development of a new class of transformative medicines. gempex supports in all tasks related to quality assurance and quality control in the field of biomedical research at the highest level.

...

Product-specific Certificate Required. What does that mean specifically? What needs to be done prior to finalization of the EU MDR?

...

Concept and implementation of Established Conditions (EC) and Product Lifecycle Management (PLCM) Document." -- New technical article from gempex -- New instruments of the ICH Q 12 guideline

...