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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
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Preclinical & Laboratory Foundations - courses at £229
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
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  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
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  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

About

The ISO 45001:2018 — Practical Occupational Health & Safety Management and Implementation Course & Certification is designed to provide a practical understanding of occupational health and safety management systems. The course focuses on implementing ISO 45001 requirements to reduce workplace risks, prevent incidents, and improve safety performance.
This course covers ISO 45001:2018 basics, hazard identification, risk assessment and control, incident management, emergency preparedness, documentation, and audit readiness. Upon completion, learners receive a certification in ISO 45001:2018 implementation and OHS management.

Who Should Enrol?

  • Health & Safety (HSE) Professionals
  • Quality and Compliance Teams
  • Manufacturing and Pharmaceutical Employees
  • Engineering and Maintenance Staff
  • Safety Officers and Supervisors
  • Regulatory Affairs Professionals
  • Life Science, Pharmacy, Chemistry, and Engineering Graduates

What you will learn

Understand the fundamentals of ISO 45001:2018 and Occupational Health & Safety Management Systems (OHSMS), including structure, scope, and key requirements.

Learn how to apply ISO 45001 clauses in practice, covering context of the organization, leadership, planning, support functions, and operational controls.

Gain knowledge of risk-based thinking in occupational health and safety, including hazard identification, risk assessment, incident management, and performance evaluation.

Develop an understanding of continuous improvement, implementation strategies, and audit readiness to ensure effective workplace health and safety compliance.

Course Syllabus

  1. Introduction to ISO 45001 + OHSMS
  2. What ISO 45001 is
  3. Why it matters
  4. OHSMS scope
  5. Vs OHSAS 18001
  6. Hazards we manage
  7. Benefits
  8. A life-sciences site with OHS at the core
  9. What inspectors look for
  10. OHS risk categories — what a life-sciences site manages

  1. Structure of ISO 45001 (Annex SL)
  2. Annex SL HLS
  3. Common elements
  4. ISO 9001 overlap
  5. ISO 14001 overlap
  6. Integrated system
  7. Savings
  8. One integrated management system in a pharma
  9. Annex SL HLS — the shared 10-clause structure

  1. Context of the Organisation (Clause 4)
  2. 4.1 External issues
  3. 4.1 Internal issues
  4. 4.2 Interested parties
  5. 4.3 OHSMS scope
  6. 4.4 OHSMS
  7. Scope clarity
  8. A CRO OHSMS scope

  1. Leadership + Worker Participation
  2. 5.1 Leadership
  3. 5.2 Policy
  4. 5.3 Roles
  5. 5.4 Consultation + participation
  6. Safety culture
  7. Worker representatives
  8. Meaningful worker participation in a lab
  9. Worker participation under Clause 5.4 — what it looks like

  1. Planning + Risk Management (Clause 6)
  2. 6.1.2 Hazard ID
  3. 6.1.2 Risk assessment
  4. Hierarchy of controls
  5. 6.1.3 Legal requirements
  6. 6.1.4 Risks + opportunities
  7. 6.2 Objectives
  8. Hierarchy of controls in a chemistry lab
  9. 5x5 risk matrix — simple + defensible

  1. Support Functions (Clause 7)
  2. 7.1 Resources
  3. 7.2 Competence
  4. 7.3 Awareness
  5. 7.4 Communication
  6. 7.5 Documented information
  7. Records
  8. Competence-based training in a biologics site
  9. Competence cycle — five steps

  1. Operational Control (Clause 8)
  2. Safe systems of work
  3. Operational planning
  4. Management of change
  5. Emergency preparedness (8.2)
  6. Contractors
  7. Procurement + outsourcing
  8. Emergency preparedness on a solvent recovery unit
  9. Permit-to-work system — eight essentials

  1. Performance Evaluation (Clause 9)
  2. 9.1 Monitoring
  3. 9.1.2 Compliance
  4. 9.2 Internal audit
  5. 9.3 Management review
  6. Leading indicators
  7. Lagging indicators
  8. A mature OHS dashboard
  9. Management review — mandatory inputs (9.3.2)

  1. Improvement + Incident Management (Clause 10)
  2. 10.2 Incident + NC
  3. Corrective action
  4. Preventive action
  5. Effectiveness check
  6. 10.3 Continual improvement
  7. Culture
  8. A needlestick incident, investigated well
  9. Incident investigation template — eight stages

  1. Implementation + Audit Readiness
  2. Gap assessment
  3. 90-day plan
  4. 180-day plan
  5. Certification audit
  6. Common findings
  7. Audit readiness
  8. A 180-day implementation in a mid-size pharma

Course Benefits

Benefits cpd_points icon
CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

Benefits certification icon
Certification

Receive a personal certificate to show your subject knowledge on course completion.

Benefits affordable icon
Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any changes to ISO 45001:2018, ISO 19011:2018, ILO-OSH 2001, OSHA 29 CFR 1910 / 1926, and UK HSE / EU OSHA guidance as our training courses are constantly monitored, reviewed and updated.

Benefits industry_experts icon
Learn from Industry Experts

The course content has been developed by NEBOSH-qualified health & safety practitioners and IRCA-certified ISO 45001 lead auditors to ensure that learners can implement an OH&S management system end-to-end. Every lesson follows the same pedagogical rhythm — concept cards, a real workplace case study, an audit-flag warning, a floor-side checklist, a standards map, a do/do-not rulebook, and a scenario knowledge check.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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