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Pharma and Medical Device Industry – Introduction

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Introduction

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Skills for those aiming to join the sector

Fifteen of the world’s top 25 healthcare companies are located in Ireland with the sector sustaining over 40,000 jobs. This course is intended to give those aiming to move from general industry to the Pharmaceutical and Medical Device manufacturing... Read More

Fifteen of the world’s top 25 healthcare companies are located in Ireland with the sector sustaining over 40,000 jobs. This course is intended to give those aiming to move from general industry to the Pharmaceutical and Medical Device manufacturing sectors, a good grounding in the principles that govern the manufacture of both Pharmaceuticals and Medical Devices and to equip them for a smooth transition to working in a highly regulated environment. The course aims to highlight the differences between the healthcare manufacturing sectors and the rest of industry, whilst exploring with attendees the benefits that they can bring to employers within the healthcare sector.

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What's covered?

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Laws, Regulations and Guidelines Governing the Pharmaceutical and Medical Device Industries:

  • Regulations, Guidance, Standards and Harmonised Standards
  • Europe: The Pharmaceutical and Medical Device Directives, CE Marking and EU GMPs
  • US: The FDA, USA CFRs, cGMPs
  • Japan, Australia, Canada and Global Harmonization and ICH Q7
  • Ireland: The Role of the IMB and Notified Bodies
  • ISO 13485 and its relationship with ISO 9000 and the FDA QSR (Part 820)
  • CAPA and Continuous Improvement in the Pharmaceutical Industry and ICH Q10

Hygiene and Sterilization:

  • The definition of Sterile and Sterilization Techniques
  • Cleanroom manufacturing and cleanroom technologies. Equipment Design and Techniques for Clean Manufacture. Personnel Hygiene requirements
  • Cleaning Validation
  • The role of the Qualified Person

Process Validation:

  • Principles of Validation in the Pharmaceutical and Medical Device manufacturing
  • Regulations and guidance covering validation; FDA, ISPE etc
  • Process design and characterization
  • Process Validation; VMP, IQ, OQ, PQ

Computer Systems and Software Validation:

  • The life cycle approach to computer systems and software validation
  • Regulations and Guidance and GAMP 5 and ICH Q11
  • Validation Documentation: URS, FDS, Traceability Matrices, IQ, OQ, PQ
  • Electronic Signatures and Records regulations 21 CFR Part 11
  • Laboratory Systems Validation and Method Validation

Risk Management:

  • The application of Risk Management in the Pharmaceutical and Medical Devices industries
  • Risk Management Regulations and Guidance and ISO 14971 and ICH Q9

Good Documentation Practice:

  • Controlled documents. How to complete records correctly. The 2-3-4 date format. Corrections and amendments. Audits and dealing with auditors

Who’s who in the Healthcare Sector:

  • The major players in Pharmaceutical and Medical Device Manufacturing in Ireland and on the Global Scene

A guide to Jargon and Abbreviations:

  • Common terminology and abbreviations used in the Pharmaceutical and Medical Devices world and how these differ from other industries e.g. URS, ICH, P&ID, GXP etc

The Healthcare Sector and You:

  • What you can bring to the healthcare sector
  • Your future role in Medical Devices or Pharmaceuticals

Who should participate?

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Managers, Engineers, Technical Specialists and Quality Assurance Personnel who wish to seek employment in the Pharmaceutical or Medical Device Industries would benefit greatly from completing this course. This course will be a great source of information for those about to apply for positions within the Pharmaceutical and Medical Device industries. By equipping attendees with the relevant information and helping them to maximise their own experience, this course will allow attendees to compete on a more equal footing with other candidates who already have experience within these industries.

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Understand the principles that govern healthcare manufacturing.
  • Understand the regulatory framework and identify the regulatory bodies and regulations that apply in various world markets such as the US, Europe, Canada and Asia.
  • Understand the hygiene and sterility aspects of healthcare manufacturing.
  • Understand the validation approach as applied in Medical Devices and Pharmaceuticals to:
    • Processes
    • Computer Systems
    • Laboratory Systems
    • Cleaning
  • Understand how Risk Management techniques are applied in the healthcare sector.
  • Identify the key documents used in the industry such as URS, FDS, VMP, IQ, OQ and PQ.
  • Identify possible future career roles within the Pharmaceutical or Medical Device Industries

Who are the tutors?

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SnapshotSnapshot

Course Code
LS006
Duration
2 training days
Delivery Mode
Available for In-House and delivered through Virtual Classroom Training 
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Pharma and Medical Device Industry – Introduction

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Pharma and Medical Device Industry – Introduction

Duration: 2 days
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