ANALYTICAL INSTRUMENTQUALIFICATION & COMPUTER SYSTEMS VALIDATION
2025-11-06 08:00 - 2025-11-07 17:00 UTC | Protea Hotel Johannesburg Balalaika Sandton, Johannesburg, South Africa
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs, and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection.
The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.
This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.
The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk=based approach to compliance. Interactive exercises will be dispersed into and in-between presentations.

PHARMACEUTICAL UTILITIES WATER, HVAC,STEAM & PROCESS AIR
2025-12-03 08:00 - 2025-12-04 17:00
This 3 day course will cover important pharmaceutical utility systems that are important for proper functionality of the manufacturing plant, such as:
Water (Potable Water, Purified Water and Water for Injection
Steam (Plant, Industrial)
Pure Steam/Clean Steam
System and Process Gases (Compressed air, Nitrogen)
References:

ISPE Baseline Guide – Water and steam systems
Approaches to commissioning and qualifications of pharmaceutical waterand steam systems.
Sampling for pharmaceutical water, steam and process gases.
Good practice guide – Heating, ventilation and air conditioning (HVAC).Oral solid dosage forms.
Sterile product manufacturing facilities
PIC/S Guideline, WHO Guidelines and Technical Reports
ISO 14644, BP and Phar. Eur.USP, PDA Letter – ISO 22519, PDA
