Introduction
The aim of this course is to examine how companies manage compliance with the regulations, codes of practice and guidelines that cover the Life Sciences Industries.
On completion of this training course, you will be able to:
- Understand the regulatory framework for the Life Sciences Sector
- Appreciate the different regulatory bodies that work in this sector
- Understand the principles of Good Manufacturing Practices (GMP)
- Understand the impacts of Good Manufacturing Practices on Facility Layout and the Manufacturing Process
- Understand the impact of operating personnel on GMP
- Appreciate best practice in standard operating procedures and record keeping
- Understand how production non-conformances and complaints are handled
- Understand how self- inspection and auditing systems work
Who is this course for?
This course is ideal for those who are new to working in the Life Sciences sector and want to learn about the requirements for Quality and GMP in their work operations.
This course is also appropriate for anyone working in Manufacturing Teams in the Life Sciences Sector who wish to update their training in Good Manufacturing Practices.
Course Content
This particular course consists of 11 video lessons. Each video is approximately 4 to 10 minutes in length. At the end of each video lesson there is a quiz that will test your knowledge of the material. A transcript is available for each lesson so you can real along with the video or download and print to study later. This course is completely self-paced. Watch and study when and wherever you want.
The estimated course duration is 8 hours.
The lesson breakdown for this course is as follows:
- Lesson 1: Regulatory Bodies and Legislation
- Lesson 2: The principles of GMP
- Lesson 3: Facility Design
- Lesson 4: The Manufacturing Process
- Lesson 5: Validation
- Lesson 6: Gowning and Personal Hygiene
- Lesson 7: Cleaning and Sterilisation
- Lesson 8: Standard Operating Procedures
- Lesson 9: Records and Non-Conformances
- Lesson 10: Complaints and Recall
- Lesson 11: Self Inspection and Audits
On successful completion of this course all students will be awarded a Certificate of
Completion. This certificate confirms you have completed all the video lessons for
every module and fully met all the requirements of the course.
To achieve this award all the assessment quizzes for each lesson must be passed. The pass grade for each quiz is 80%.You can retake lesson quizzes as often as you like.
The Assessment Method
There’s a quiz at the end of each lesson to test your understanding of the material. To successfully complete this course, you must pass the quiz for each lesson. Once all the lessons have been completed, you can then download and print the People & Process completion certificate. So let’s get started! Click on the Lessons to begin
