Training & Public Events
It is ultimately human, who is the key element in the assurance of medicinal product quality and safety for the patient. Personnel has to be trained, scientific and process knowledge must be communicated and shared within an organization and between the participants of the pharmaceutical market. Internal and external training, seminars/webinars, conferences and other public events are an integer part of pharmaceutical business activities addressing knowledge and personnel qualifications management.
Tarqvara Pharma Technologies specialists have years of experience in organizing and conducting GxP training and related public events that includes:
- Face-to-face and distance learning sessions on basic topics of GMP, GDP, industrial hygiene, documentation, qualification and validation practices, and main pharmaceutical manufacturing processes, as well as on specialized topics such as computerized systems validation (CSV), records and data integrity (RDI), GAMP, serialization/aggregation, monitoring systems, cleanrooms and HVAC, pharmaceutical water systems, containment and production of high-potent drugs
- Development of training programs and training materials on GMP/GDP/GAMP
- Organization of qualification tests for trainees and personnel of pharmaceutical companies
- Preparation of presentations and participation in seminars, webinars, conferences, etc. on pharmaceutical topics
- Promotion of customer products and services
The subjects of our GxP training include:
General GxP Topics:
- Introduction into GMP
- Hygienic Requirements in Cleanrooms
- Basics of Qualification and Validation
- Validation Master Plan (VMP)
- Risk Analyses (RA)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Special Topics:
- Computerized Systems Validation / GAMP5 / 21 CFR Part 11
- Records and Data Integrity
- GxP-Compliant Design of Electronic Systems
- Serialization and Track & Trace
- GMP-Monitoring Systems
- Clean Room Systems
- HVAC Systems
- Pharmaceutical Water Systems (PW, WFI, PS)
- Compressed Air & Gas Systems
- Weighing and Dispensing
- Cross-Contamination and Cleaning
- Sterile & Aseptic Solution Preparation Systems
- Sterile & Aseptic Filling
- Sterilization Processes
- Freeze-Drying Processes
- OSD Processes
- Primary and Secondary Packaging
- Airlocks
- Toxic Facility Design and Containment Systems
- Visual Aspects of GxP: Labelling, HMI, Packaging and Documentation
- Legacy Equipment (Retrospective) Qualification
See also:
GMP/GxP Consulting
Creating Presentations
Audit / Expert Review
Qualification / Validation / Commissioning