News Previous 1 .... 12 13 14 .... 20 Next 02/19/2021 ICH Q 12 Pharmaceutical Product Lifecycle Management Concept and implementation of Established Conditions (EC) and Product Lifecycle Management (PLCM) Document." -- New technical article from gempex --… ... 02/12/2021 Cleaning Validation in the Field of GMP Training course on cleaning validation in the field of GMP on 03.03.2021: gempex supports as GMP expert in the topics "basics of cleaning validation"… ... 01/21/2021 Set-up of Standard-Compliant Quality Managements Systems - Structured Approach for the Creation or Redesign of a QMS New technical contribution from gempex -- Creating or redesigning quality assurance systems in a targeted manner -- a condensed, practical guide: key… ... 01/15/2021 Handling of Foreign Particles in APIs and Excipients Foreign particles in starting materials and active ingredients are an unwanted contaminant that can later be found in the drug itself. And this can… ... 12/17/2020 GDP - be Ready for Anything: Vaccine and Drug Distribution along EU Regulations Logistics for Pharmaceuticals - Qualification of Transport Service Providers - Good Distribution Practices. The distribution of COVID-19 vaccines -… ... 11/18/2020 Change Control and GMP Compliance In order to meet regulatory requirements even after changes in the manufacturing process of active ingredients or pharmaceutical and biotechnological… ... 10/26/2020 EU MDR: Transitional Period Ends on May 26, 2021 The transitional period for the new EU Medical Device Regulation (MDR) ends on 26th May. It will bring significant changes for medical device… ... 10/23/2020 Swissmedic Establishment License for an Unlimited Period - Save time, effort and money and get an inspection-ready QMS ... 10/22/2020 EU GMP Annex 1 - Manufacture of Sterile Medicinal Products and Contamination Control Strategy Quality Management in the Manufacture of Sterile Medicinal Products - How Companies can Already Prepare Well Now ... 10/15/2020 The GDP Audit - Passing tests and inspections safely Live Online Training "The GDP Audit" of the ECA Academy on 28 and 29 October 2020 with Dr. Martin Melzer, Principal Consultant at gempex, as main… ... Previous 1 .... 12 13 14 .... 20 Next