Test the organisation's response to pharmaceutical process validation under conditions that are less than ideal.
Validating Pharmaceutical Manufacturing Processes
Develop the judgement and the documentation needed to run pharmaceutical process validation properly.
📍 Tripoli🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Accreditation bodies assess pharmaceutical process validation on documented evidence of consistent practice. Cost pressure and quality expectations on this part of health and pharmaceutical services are rising at the same time. Progress on the wider health and pharmaceutical services agenda is usually lost in the gap between approval and execution. Content is organised around the decisions practitioners actually face in pharmaceutical process validation, not around theory headings. Post-incident reviews keep identifying weaknesses in the practice within health and pharmaceutical services that were visible long before the incident. Every module pairs a short input on this part of health and pharmaceutical services with structured practice on the participant's own material. They gain the ability to sequence improvements to pharmaceutical process validation in an order their organisation can absorb. The programme suits teams tackling this area of health and pharmaceutical services together as readily as individuals attending alone. Participants leave with a plan for the wider health and pharmaceutical services agenda sized to what their organisation can realistically absorb.
Expected Learning Outcomes
Manage the supply chain and cold chain supporting pharmaceutical process validation.
Plan staffing and rota cover appropriate to demand in pharmaceutical process validation.
Prepare a short, evidence-based briefing on pharmaceutical process validation for senior management.
Plan continuity of pharmaceutical process validation during surge, outbreak and emergency.
Control cost per episode within pharmaceutical process validation without shifting risk to patients.
Adapt recognised practice on pharmaceutical process validation to local constraints without hollowing it out.
Who Should Attend
Accreditation and compliance officers preparing evidence on pharmaceutical process validation.
Nursing managers and clinical supervisors delivering pharmaceutical process validation.
Analysts producing the data on which decisions about pharmaceutical process validation rest.
Pharmacists and pharmacy managers involved in pharmaceutical process validation.
Procurement and contracting staff whose agreements set obligations around pharmaceutical process validation.
Regulatory affairs specialists handling pharmaceutical process validation.
Course Modules
Pharmaceutical process validation: supply, cold chain and availability
2 sessions · 8 pointsSession 1Matching staffing on pharmaceutical process validation to real demand
- Confirm that contractual obligations around pharmaceutical process validation are understood.
- Prepare the response for the most likely failure in pharmaceutical process validation.
- Decide what will be stopped to create capacity for pharmaceutical process validation.
- Set out the decisions in pharmaceutical process validation that require sign-off and by whom.
Session 2Auditing pharmaceutical process validation at the bedside, not in the binder
- Map the clinical workflow for pharmaceutical process validation as it is actually performed.
- Check that consent processes within pharmaceutical process validation are genuinely informed.
- Set the review interval for pharmaceutical process validation and who attends.
- Identify the data already collected that bears on pharmaceutical process validation.
Pharmaceutical process validation: infection prevention and patient safety
2 sessions · 8 pointsSession 1Building lasting competence in pharmaceutical process validation
- Establish what evidence demonstrates pharmaceutical process validation is under control.
- Compare the cost of pharmaceutical process validation with the cost of its absence.
- Confirm competence and continuing development for staff delivering pharmaceutical process validation.
- Confirm patient data handled within pharmaceutical process validation meets confidentiality obligations.
Session 2Investigating an adverse event involving pharmaceutical process validation
- Confirm licensing and regulatory requirements applying to pharmaceutical process validation are met.
- Measure patient experience of pharmaceutical process validation and feed it back to the team.
- Write down the assumptions underpinning the approach to pharmaceutical process validation.
- Apply structured root cause analysis to the last adverse event involving pharmaceutical process validation.
Pharmaceutical process validation: quality indicators and patient outcome
2 sessions · 8 pointsSession 1Making incident reporting on pharmaceutical process validation safe for staff
- Review whether pharmaceutical process validation is aligned with the objectives of the clinical service.
- Identify where judgement in pharmaceutical process validation is legitimate and where it is not.
- Assign responsibility for keeping documentation of pharmaceutical process validation current.
- Confirm the incident reporting route for pharmaceutical process validation is quick and non-punitive.
Session 2Infection risk created by pharmaceutical process validation
- Identify infection transmission risks created by pharmaceutical process validation and control them.
- Cost pharmaceutical process validation per episode and identify avoidable waste.
- Close the loop: confirm changes to pharmaceutical process validation improved the indicator they targeted.
- Audit pharmaceutical process validation by observing practice, not by reading policy.
Pharmaceutical process validation: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1Reading the current state of pharmaceutical process validation honestly
- Reduce the variation in how pharmaceutical process validation is carried out between teams.
- Assemble the accreditation evidence pack for pharmaceutical process validation.
- Define escalation criteria for deterioration detected through pharmaceutical process validation.
- Match staffing levels on pharmaceutical process validation to measured demand across the week.
Session 2The cost of pharmaceutical process validation and how to present it
- Plan the sequence in which improvements to pharmaceutical process validation will be introduced.
- Select quality indicators for pharmaceutical process validation that measure outcome rather than activity.
- Build the internal briefing that explains pharmaceutical process validation to those affected.
- Draft the minimum viable clinical protocol for pharmaceutical process validation.
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
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