Translate policy on good pharmaceutical manufacturing practice into procedures that hold up under day-to-day pressure.
Managing Pharmaceutical Manufacturing Under Good Manufacturing Practice
Develop the judgement and the documentation needed to run good pharmaceutical manufacturing practice properly.
📍 Tunis🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Clinical staff will work around a process for good pharmaceutical manufacturing practice that obstructs care, and they will be right to. Variation in manufacturing practice between shifts and sites is where avoidable harm lives. Progress on the health and pharmaceutical services capability is usually lost in the gap between approval and execution. Discussion is anchored to worked examples of good pharmaceutical manufacturing practice rather than to abstract argument. It treats the practice within health and pharmaceutical services as an operating discipline and equips participants to run it as one. Where manufacturing practice is measured, it improves; where it is only discussed, it drifts. It is designed for mixed groups, so that good pharmaceutical manufacturing practice is examined from more than one functional angle. They leave able to brief senior management on manufacturing practice in terms that support a decision. Work concludes with a self-assessment of this part of health and pharmaceutical services that participants can repeat annually.
Expected Learning Outcomes
Assess and control infection risk associated with manufacturing practice.
Agree the first three actions on good pharmaceutical manufacturing practice that will be taken on returning to work.
Design escalation for clinical deterioration detected through manufacturing practice.
Sequence improvements to good pharmaceutical manufacturing practice so that each step makes the next one easier.
Design a process for manufacturing practice that clinical staff can follow without obstructing care.
Measure patient experience of good pharmaceutical manufacturing practice and act on what it shows.
Who Should Attend
Clinical department heads responsible for good pharmaceutical manufacturing practice.
Health information and records staff supporting manufacturing practice.
Technical staff being prepared for supervisory responsibility over good pharmaceutical manufacturing practice.
Members of committees that take decisions affecting manufacturing practice.
Infection prevention and control practitioners covering good pharmaceutical manufacturing practice.
Hospital and health facility managers accountable for manufacturing practice.
Course Modules
Good pharmaceutical manufacturing practice: clinical process design and workflow
2 sessions · 8 pointsSession 1Medication safety checkpoints inside good pharmaceutical manufacturing practice
- Confirm competence and continuing development for staff delivering good pharmaceutical manufacturing practice.
- Check that consent processes within manufacturing practice are genuinely informed.
- Identify infection transmission risks created by good pharmaceutical manufacturing practice and control them.
- Test the procedure for manufacturing practice against a realistic scenario.
Session 2Auditing manufacturing practice at the bedside, not in the binder
- Prepare the summary of good pharmaceutical manufacturing practice that senior management will read.
- Check that manufacturing practice still works when volumes rise unexpectedly.
- Assemble the accreditation evidence pack for good pharmaceutical manufacturing practice.
- Close the loop: confirm changes to manufacturing practice improved the indicator they targeted.
Manufacturing practice: quality indicators and patient outcome
2 sessions · 8 pointsSession 1The cost of manufacturing practice and how to present it
- Set escalation thresholds for good pharmaceutical manufacturing practice that work out of hours.
- Select quality indicators for manufacturing practice that measure outcome rather than activity.
- Confirm the incident reporting route for good pharmaceutical manufacturing practice is quick and non-punitive.
- Identify the data already collected that bears on manufacturing practice.
Session 2Keeping supply and cold chain reliable for manufacturing practice
- Define acceptance criteria for good pharmaceutical manufacturing practice in advance.
- Define the trigger that would require manufacturing practice to be redesigned.
- Measure patient experience of good pharmaceutical manufacturing practice and feed it back to the team.
- Record what was learned when manufacturing practice did not go as planned.
Manufacturing practice: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1What has to be agreed before work on manufacturing practice starts
- Cost good pharmaceutical manufacturing practice per episode and identify avoidable waste.
- Match staffing levels on manufacturing practice to measured demand across the week.
- Prepare the response for the most likely failure in good pharmaceutical manufacturing practice.
- Set out the decisions in manufacturing practice that require sign-off and by whom.
Session 2Building the method for good pharmaceutical manufacturing practice step by step
- Rank the weaknesses in good pharmaceutical manufacturing practice by consequence rather than by ease of fixing.
- Draft the minimum viable clinical protocol for manufacturing practice.
- Map the clinical workflow for good pharmaceutical manufacturing practice as it is actually performed.
- Decide what will be stopped to create capacity for manufacturing practice.
Manufacturing practice: infection prevention and patient safety
2 sessions · 8 pointsSession 1Infection risk created by manufacturing practice
- Apply structured root cause analysis to the last adverse event involving good pharmaceutical manufacturing practice.
- Audit manufacturing practice by observing practice, not by reading policy.
- Reduce unwarranted variation in good pharmaceutical manufacturing practice between shifts and sites.
- Verify cold chain and storage conditions for materials used in manufacturing practice.
Session 2Consent, confidentiality and ethics in manufacturing practice
- Distinguish symptoms from causes when good pharmaceutical manufacturing practice underperforms.
- Review whether manufacturing practice is aligned with the objectives of the clinical service.
- Build medication safety checks into good pharmaceutical manufacturing practice at the point of highest risk.
- Write down the assumptions underpinning the approach to manufacturing practice.
Choose the package that suits you
Silver Package
At least 3 people
USD1,250
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Gold Package
At least 3 people
USD1,850
- 5-night stay in a 5-star hotel
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Complete your registration
We will contact you within one business day to confirm.