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Pharmaceutical GMP Training

NSF International, Health Sciences
Übersicht
Beginn: 23.11.2021 Kirkbymoorside
Präsenzkurs / vor Ort
3 Tage
2.520 GBP inkl. MwSt.
Englisch
Kurse
NSF International, Health Sciences

Beschreibung

Pharmaceutical GMP Training

About This Course

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.

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.

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
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Inhalte / Module

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

We also provide:

  • Up-to-the-minute information on new pharmaceutical GMP initiatives and regulations
    • Key changes to global GMP regulations
  • Practical advice on dealing with the difficult areas of pharmaceutical GMP
  • Access to experts for opinion on your GMP concerns

Nutzen & Mehrwert

Why Choose NSF

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 very popular pharmaceutical quality systems auditor/lead auditor training program.

Bring your questions and tap into the great experience 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
  • An ideal starting point for our modular QP training program

Kostenzusatz

Discounts offered to NHS staff, regulators and charities.

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Kontaktinformation NSF International, Health Sciences

NSF International, Health Sciences

22-24 West End
YO62 6AF Kirbymoorside

 Telefonnummer anzeigen
www.nsfpharma.org

NSF International, Health Sciences

NSF International, Health Sciences

NSF International provides education and training services to lead organisations in the healthcare industry. Courses in health science from NSF International have one goal – to bring change that drives improvements in workplaces. Globally known for high-quality content, NSF International...


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