Pharmaceutical Good Manufacturing Practices
Pharmaceutical quality depends on consistent, traceable practices. Connect Good Manufacturing Practices with operational tasks, documentation and on-site controls. Strengthen your contribution to process control and deviation prevention.
- Duration
- 2 days 14 hours
- Code
- ENT19FR Code
Presentation
Pharmaceutical handling can have extremely serious consequences if it is not carried out responsibly and systematically. This course teaches the legal standards and safety practices for pharmaceutical manufacturing.
Objectives
- Understand and apply GMP rules within the company's quality approach.
- Recognise the risks and consequences of deviations at your workstation.
Program
Introduction
- The regulatory foundations.
- ANSM: organisation, role and mission.
- How a pharmaceutical product is developed.
- Dosage forms.
The different GMP chapters
- Quality management: quality assurance and quality control.
- Personnel: competence and training, hygiene and safety.
- Premises and equipment: zoning, material flow organisation, maintenance and cleaning.
- Documentation: identification and procedures.
- Production: weighing and calibration; manufacturing equipment types; primary and secondary packaging and line clearance.
- Quality control: role and types of checks.
- Sterile products, sampling, filtration, sterilisation and decontamination methods.
- Responding to production quality problems: defects, deviations and nonconformities.
- Self-inspections.
Practical exercises and assessment
Each participant receives a summary reference sheet.
Audience
Anyone working at a pharmaceutical site or for a carrier, subcontractor or supplier serving the pharmaceutical sector.
Prerequisites
None.
Teaching and assessment methods
- Initial skills assessment
- Training materials provided to participants
- Continuous assessment throughout the course
- End-of-course feedback questionnaire
- Combination of theory and practical application
- Attendance records
- Post-course follow-up evaluation
Dates and sessions
Choose the date and delivery format that suit you.
No upcoming sessions are currently available.
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