BEGIN:VCALENDAR VERSION:2.0 PRODID:-//TYPO3/NONSGML Calendarize//EN BEGIN:VEVENT UID:calendarize-good-manufacturing-practice-gmp-glp-und-gcp-basics-and-ext ended-requirements-in-the-pharmaceutical-environment DTSTAMP:20240328T222642Z DTSTART:20230213T080000Z DTEND:20230214T160000Z SUMMARY:Good Manufacturing Practice (GMP\, GLP und GCP) basics and extende d requirements in the pharmaceutical environment DESCRIPTION:Lecturers: Dr. Heinrich Prinz (PDM-Consulting)\, Dr. Christoph Prinz (Head of Quality Assurance GMP & Qualified Person of the company "B ioNTech SE")\nTopics of the workshop\nIn this workshop\, you will learn th e basic requirements for a quality management system and gain insight into concrete activities\, such as risk analysis for a manufacturing process a nd conducting audits in the quality assurance environment of a pharmaceuti cal product. You will also learn about the requirements of clinical trials \, which are a basic prerequisite for the marketability of pharmaceuticals . You will learn in detail\, which activities and tasks quality control mu st fulfill and cover in a pharmaceutical company. The distinction between quality assurance\, manufacturing and the tasks of the legally responsible persons\, in particular the Qualified Person\, is important here.\n Regu latory requirements for the manufacturing of drugs (Content and structure of the regulations for the manufacturing of drugs in respect to developmen t\, production\, registration and distribution) What does GMP mean – „ What do I need to know about GMP in the pharmaceutical environment? What a re the differences between GMP – GLP – GCP Legal Responsibilities GM P and Quality Management GMP and the Production of a Medicinal Product GMP and the Quality Control of Medicinal Product Performance of clinical trials ATMP’s\, Protein Engineering\, Tissue Engineering Medical devi ces\, Combination products \nLecturer \nDr. Heinrich Prinz studied chemist ry and genetics and worked for many years in the pharmaceutical industry\, where he was responsible for quality management in the pharmaceutical\, m edical devices and diagnostics sectors. His main focus is on the developme nt and implementation of quality management systems according to GMP Part I and II and integrated management systems as well as the execution of aud its and trainings. With PDM-Consulting he advises companies in the product ion of pharmaceuticals\, medical devices and in-vitro diagnostics regardin g quality management and trains employees as well as PhD students.\nLocati on: Presence (presence is planned otherwise online\, no hybrid course)\nEC TS: 1\nParticipants: max. 20\nRegistration for the workshop via Stud.IP (w inter term 2022/2032)\nOrganized by OLTECH\ncontact: oltech@uol.de X-ALT-DESC;FMTTYPE=text/html:
Lecturers: Dr. Heinrich Prinz (PDM-Consulting)\, Dr. Christoph Prinz (Head of Qual ity Assurance GMP &\; Qualified Person of the company "BioNTech SE")
\nTopics of the workshop
\nIn this workshop\, y ou will learn the basic requirements for a quality management system and g ain insight into concrete activities\, such as risk analysis for a manufac turing process and conducting audits in the quality assurance environment of a pharmaceutical product. You will also learn about the requirements of clinical trials\, which are a basic prerequisite for the marketability of pharmaceuticals. You will learn in detail\, which activities and tasks qu ality control must fulfill and cover in a pharmaceutical company. The dist inction between quality assurance\, manufacturing and the tasks of the leg ally responsible persons\, in particular the Qualified Person\, is importa nt here.
\nLecturer
\nDr. Heinrich Prinz studied chemistry and genetics and worked for many years in the pharmaceutical industry\, where he was responsible for quality management in the pharmaceutical\, medical devices and diagnostics sectors. His main focus is on the development and implementation of quali ty management systems according to GMP Part I and II and integrated manage ment systems as well as the execution of audits and trainings. With PDM-Co nsulting he advises companies in the production of pharmaceuticals\, medic al devices and in-vitro diagnostics regarding quality management and train s employees as well as PhD students.
\nLocation: Presence (p resence is planned otherwise online\, no hybrid course)
\nE CTS: 1
\nParticipants: max. 20
\nRegistration for the workshop via Stud.IP (winter term 2022/2 032)
\nOrganized by OLTECH
\ncontact : oltech@uol.de
LOCATION: END:VEVENT END:VCALENDAR