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Pharmaceutical GMP Training

Dates

Times

2 days8 hrs VILT

Location

Virtual Learning

Availability

About This Course

Whether you’re just starting in the industry or an experienced staff member, this highly interactive GMP pharmaceutical training course will teach you how to apply pharmaceutical GMP in your workplace and keep you up to date with industry requirements.

Covering important sections of the ever-changing EudraLex Volume 4, you will leave with a thorough understanding of the essentials of GMP. You will be able to identify up-to-the-minute information on new and existing pharmaceutical GMP initiatives and regulations.

The course provides an excellent opportunity to share your GMP questions with experienced industry experts and get practical advice first-hand.

Our virtual instructor-led training course provides an engaging learning experience. Our team will email full details following registration.

Key Learning Objectives

On completion of this course, learners will be able to:

  • Explain the origin and reasons for GMP
  • Apply the practical interpretation of GMP expectations and best practices
  • Identify EudraLex and PIC/S expectations

Course Outline

  • Overview of EU law and requirements relating to medicines
  • EudraLex Volume 4,
  • Quality Risk Management - ICH Q9
  • Pharmaceutical quality systems and ICH Q10
  • Management responsibilities
  • Documentation and records
  • Validation - the basics
  • Supplier assurance
  • Facility design and GMP requirements for different dose forms/routes of administration
  • Good Control Laboratory Practice
  • Self-inspections
  • Change management
  • Investigations - deviations and CAPA
  • Complaints, quality defects and recalls
  • Training

Who Should Attend

Attend this pharmaceutical GMP course if you work in management, QA, QC, production, engineering and supply chain, and you want to broaden your knowledge in pharmaceutical GMPs. This course is suitable for newcomers to the industry who wish to understand the essentials of pharmaceutical GMP.

The course will also benefit suppliers of materials and services to the pharmaceutical industry to understand GMP requirements.

Why Choose NSF

Bring your questions and tap into the great experience and knowledge from helpful tutors. In addition, this course offers:

  • Tutors with real credibility and experience to bring pharmaceutical GMP training to life with examples and real-life stories
  • Training designed to reach all learning styles and preferences
  • Detailed reference material to take away and to become instantly useful

This course repeatedly achieves the highest customer satisfaction level of any of our courses, with 95 percent of delegates rating it very good or excellent. It also meets the entry-level GMP training requirement for our popular pharmaceutical quality systems auditor/lead auditor training program so that you can continue your training journey with NSF.

Course Tutors

Course tutors will be selected from the following:

Samantha Clack - A working QP, lead auditor and QP trainee coordinator, Samantha has an up-to-date knowledge of GMP requirements and hands-on experience implementing and meeting regulatory expectations.

David Waddington - David has broad experience in QA and manufacturing management, working with various dosage forms for global supply, including solids, liquids, sterile products, food supplements, and natural products.

Catherine Kay - Catherine has extensive pharmaceutical operations management, technical and QA experience spanning more than 23 years, gained working for a major international pharmaceutical organization, a start-up manufacturing organization and, most recently, a contract manufacturing organization in a corporate operations role.

Rachel Carmichael – Rachel has nearly 30 years GMP experience, including acting as an MHRA Inspector for over 10 years. Eligible as a Qualified Person, Rachel has broad understanding of the many different ways with which companies are capable of complying.

  • Very well-arranged course! It was useful that the course explained GMP with ‘what does the patient want’ in mind and that the challenges connected with the manufacture of different kinds of dosage forms were a part of the course. After the course, it is easier for me to see the big picture within GMP.
    Gitte Albaek Nielsen
  • I really enjoyed the structured format and the exercise we had to do prior to the training. I liked this approach a lot. Breaking into working groups was also interesting and engaging.
    Florina Matei-Rutkovska
  • The standard of lecturers/presenters was excellent. Very impressed with the quality and completeness of the material covered.

    Gerrard Kemmy
    Covidien, Republic of Ireland

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