Good Manufacturing Practices and GMP Inspections for Medicines and Healthcare Products

Overview

Course name Good Manufacturing Practices and GMP Inspections for Medicines and Healthcare Products
Institution i+solutions
Location Online
Website http://www.iplusacademy.org
Language English
Contact information

Carole Piriou

cpiriou@iplussolutions.org

Phone: +31 348 748722

Details

Course objective

After having successfully completed the course, participants will be able to:

  • Appreciate the importance and need for good manufacturing practices.
  • Be familiar with the development of medicines regulation.
  • Understand the main requirements in GMP, including procedural, organizational and infrastructural aspects.
  • Have gained basic information on requirements for healthcare products such as female condoms, as a special focus.
  • Critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment.
  • Understand the need for, and the benefit of GMP inspections.
  • Be familiar with different types of GMP inspections.
  • Interpret and discuss the role of GMP inspectors.
  • Understand the inspection process and structure of an inspection report.
Sector Public
General course topics General/service course with some logistics included
Specific course topics
  • Development of medicines regulations
  • Good manufacturing practices and other related good practices
  • Quality management
  • Special focus: medical devices
  • Personnel, organisation and training
  • Sanitation and hygiene
  • Premises
  • Equipment
  • Materials
  • Good practices in production and quality control
  • Qualification and validation
  • GMP requirements for documentation
  • Complaints and recalls
  • Self inspection and quality audits
  • Introduction to GMP inspections
  • The role of the inspector
  • Types of GMP inspections
  • Inspections and inspection report
Total time commitment 24
Focus commodity Health, including RH
Commodities covered This course covers health commodities in general, with a focus on essential medicines. Medical devices such as condoms are specifically adressed.
Accredited No
Accredited by N/A
Certificate name Certificate
Degree name Certificate of completion
Attendance mode Online
Attendance description

The course is taught online on i+academy, our e-learning platform, by expert facilitators. The interactive course materials are presented sequentially under the guidance of the facilitators who assist participants, answer questions and stimulate discussions. Lessons are complemented and enlivened by online activities such as discussion forums, quizzes, and assignments. The course is accessible from anywhere at any time and allows participants easy and regular interactions with the course facilitators and other participants during the learning process.

Incentives No
Logistics Topics Coverage % (estimate) 10
Audience Open Enrollment
Pre-requisites No
Course fee $550
Course fee description

The course fee covers attendance to the online course with support from an online facilitator and enrollment in an alumni course at the end of the session, which offers participants continuous access to the course material and the online participants community after the course is over.

Discount available No
Course included in analysis No