Quality Management for Pharmaceutical and Medical Device Manufacturing
Pharmaceutical and medical device makers operating in South Africa work under strict quality expectations where a single lapse can compromise patient safety and product recalls. This course gives quality and production teams a practical grounding in good manufacturing practice, batch documentation, deviation handling, and contamination control. The focus is on building day to day quality discipline that keeps product safe and records defensible.
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Explain the principles of good manufacturing practice for regulated production.
Maintain batch records and documentation that withstand scrutiny.
Handle deviations, out of specification results, and change control correctly.
Apply contamination control and cleanroom discipline in daily work.
Manage validation and qualification records for equipment and processes.
Prepare the quality evidence needed for an inspection or customer audit.
Course outline
01Principles of Good Manufacturing Practice
02Batch Records and Documentation Discipline
03Deviation and Out of Specification Handling
04Change Control in Regulated Production
05Contamination Control and Cleanroom Practice
06Validation and Qualification Records
07Managing Nonconforming Product and Recalls
08Preparing for Inspections and Audits
Who should attend
This course is aimed at quality assurance and control staff, production supervisors, and technical personnel working in pharmaceutical, medical device, or related regulated manufacturing.
Fees are per delegate. South African venues are priced in rand; other locations and online in US dollars. Fees exclude 15% VAT where applicable. Group bookings of three or more delegates from the same organisation qualify for a reduced rate; contact us for a quotation.
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