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Course summary
3 days
2,100 - 2,170 GBP excl. VAT
English
Full time
Online courses, York
Next available date: 23/11/2021 09:00 - York

Course description

Pharmaceutical GMP

It is a legal requirement that all staff members receive Good Manufacturing Practice (GMP) pharmaceutical training as well as regular updates thereafter. Whether you’re just starting out in the industry or you’re an experienced member of staff, this intensive and highly interactive three-day GMP pharmaceutical training course is designed to teach you all you need to know about the latest EU requirements for pharmaceutical GMP.

Covering key sections of the ever-changing EudraLex Volume 4, delegates will leave with a thorough understanding of the essentials of GMP. The most popular in Europe, our pharmaceutical GMP courses are known and respected all over the globe.

Outcome / Qualification etc.

Key Learning Objectives

On completion of this course delegates will know and understand:

  • The origin and reasons for GMP
  • Key European and U.S. GMP legislation
  • The practical interpretation of GMP expectations and best practices
  • EudraLex and PIC/S expectations
  • Premises, processes, products, procedures, people and GMP

Training Course Content

Course Outline

  • Appreciation of what is important for patients
  • Developing safe medicines and where GMP fits in the lifecycle of a medicinal product
  • An understanding of global GMP and licensing requirements
  • ICH Q9: Quality Risk Management
  • Responsibility of senior management
  • Supplier assurance and oversight of supply chains
  • Facility design considerations and contamination control
  • Key utilities such as water and HVAC
  • Validation, calibration and maintenance
  • Operating an effective PQS including taking a closer look at human error, deviations, CAPA and change management
  • People and the importance of training and understanding
  • Good documentation design principles
  • Importance of packaging
  • Data integrity
  • Good control laboratory practice
  • Good distribution practices
  • Complaints, recalls and pharmacovigilance
  • Audits and self-inspections
  • PQS oversight

Course delivery details

If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Discounts

Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International, Health Sciences

NSF International provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are...


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Contact info

NSF International, Health Sciences

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

Reviews

Average rating 4.6

Based on 5 reviews.

A. Gundumonu
Course is good and useful for all streams of pharma industry.
A. Sagay-Cholewa
Perfect course materials and excellent instructor knowledge of the subject. Tutors are very experienced and friendly.
Andrew Bowen
Good knowledge from instructors, well-structured course materials.
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NSF International, Health Sciences

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