DATE: 12 & 13 July 2018 (Thursday & Friday)
TIME: 8:30 AM – 5:00 PM
VENUE: Hotel Bangi-Putrajaya, Bandar Baru Bangi, SELANGOR
The objective of this comprehensive 2-day education and training course is to provide attendees
with the essential information and tools to design and operate a multi-product factory safely. This
will help ensure that the participants to pay optimal attention to critical issues during design,
qualification and routine operation of a multi-product factory.
You will learn about:
The GMP requirements for cross-contamination control in current and future versions of PIC/S GMP Chapters 3 & 5.
Understanding the principles of HBEL (Health based exposure limit) applied to cross-contamination control.
Practical ‘Risk Assessment’ TOOLs. Understand ‘Fishbone’ (cause and effect) and ‘FMEA’ techniques.
Learn about the ISPE guidance available – RiskMaPP™ Baseline Guide, and The ISPE Good Practice Guide: Assessing the (particulate) Containment Performance of Pharmaceutical Equipment.
Mitigation measures – Factory layout, Environmental control techniques, and process equipment designs.
The relationship with Occupational Health and Safety.
Measurement of airborne contamination in the workplace.
Tools for classifying and grouping of product by risk category
Who should attend
Personnel from Manufacturing, QA/QC, Validation. Also applicable to design & construction professionals, specialist suppliers, and personnel involved in the operation of pharmaceutical factories (multi-product) where cross-contamination is a risk
Closing Date: 10 July 2018