Training & Public Events

Ultimately, it is the human element that is key to ensuring the quality and safety of medicinal products for patients. Personnel must be properly trained, and scientific and process knowledge must be communicated and shared within the organization and across the pharmaceutical market. Internal and external training, seminars/webinars, conferences, and other public events are integral parts of the pharmaceutical industry's approach to managing knowledge and personnel qualifications.

Tarqvara Pharma Technologies specialists have years of experience in organizing and conducting GxP training and related public events, which include:

• Face-to-face and distance learning sessions on fundamental topics such as GMP, GDP, industrial hygiene, documentation, qualification and validation practices, and core pharmaceutical manufacturing processes, as well as specialized topics like computerized systems validation (CSV), records and data integrity (RDI), GAMP, serialization/aggregation, monitoring systems, cleanrooms and HVAC, pharmaceutical water systems, containment, and high-potency drug production.
• Development of training programs and materials on GMP/GDP/GAMP.
• Organization of qualification tests for trainees and pharmaceutical company personnel.
• Preparation of presentations and participation in seminars, webinars, conferences, etc. on pharmaceutical topics.
• Promotion of customer products and services.

Our GxP training subjects include:

General GxP Topics:

1. Introduction into GMP / Basic GMP Training
2. Yearly Periodic GMP Training (regulatory requirement)
3. GMP-Compliant Documentation / Good Documentation Practice (GDocP)
4. Hygienic Requirements in Cleanrooms
5. Basics of Qualification and Validation
6. Validation Master Plan (VMP)
7. Risk Analyses (RA)
8. Design Qualification (DQ)
9. Installation Qualification (IQ)
10. Operational Qualification (OQ)
11. 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