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:

1. Introduction into GMP
2. Hygienic Requirements in Cleanrooms
3. Basics of Qualification and Validation
4. Validation Master Plan (VMP)
5. Risk Analyses (RA)
6. Design Qualification (DQ)
7. Installation Qualification (IQ)
8. Operational Qualification (OQ)
9. Performance Qualification (PQ)

Special Topics:

1. Computerized Systems Validation / GAMP5 / 21 CFR Part 11
2. Records and Data Integrity
3. GxP-Compliant Design of Electronic Systems
4. Serialization and Track & Trace
5. GMP-Monitoring Systems
6. Clean Room Systems
7. HVAC Systems
8. Pharmaceutical Water Systems (PW, WFI, PS)
9. Compressed Air & Gas Systems
10. Weighing and Dispensing
11. Cross-Contamination and Cleaning
12. Sterile & Aseptic Solution Preparation Systems
13. Sterile & Aseptic Filling
14. Sterilization Processes
15. Freeze-Drying Processes
16. OSD Processes
17. Primary and Secondary Packaging
18. Airlocks
19. Toxic Facility Design and Containment Systems
20. Visual Aspects of GxP: Labelling, HMI, Packaging and Documentation
21. Legacy Equipment (Retrospective) Qualification

See also:
GMP/GxP Consulting
Creating Presentations
Audit / Expert Review
Qualification / Validation / Commissioning