Course Information
This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks.
Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings.
Is this course for you?
Ideal for professionals engaged in GMP across various sectors, including:
Research and Development (R&D)
Contract Manufacturing Organisations
Manufacturing Units
Quality Control (QC) Laboratories
Auditing Roles.
What will you learn?
Event objectives - by the end of the course, delegates shall:
Have an awareness of the basic requirements of GMP
Be aware of UK and EU GMP Rules and Guidance and relevant publications
Understand the roles and responsibilities associated with GMP
Be able to contribute to and maintain quality documentation
Have a basic understanding of product lifecycle and manufacturing
Understand the requirements of GMP in the QC laboratory context
Have a basic understanding of risk management and mitigation principles
Understand the need for quality systems and quality assurance activities
Be aware of common regulatory findings.
Learning outcomes: delegates will be able to:
Implement their role within GMP with confidence and knowledge of the principle requirements
Contribute effectively to the GMP quality system and their organisation’s compliance
Comprehend where their organisation’s activities sit within the larger GMP arena
Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet.
Tutors
Tutors will be comprised of (click the photos for biographies):
Louise Handy
Director, Handy Consulting Ltd
Programme
Please note timings may be subject to alteration.
Day 1
09:30
Introductions and Scope of the Course
Understand the group requirements and the tutor's background and experience.
09:45
Background and Regulatory Environment
Setting the scene, understanding the context, key legislation.
10:30
Principles of GMP
Key points and requirements.
11:15
Break
11:30
Personnel and Responsibilities
Management and staff, duties and accountabilities.
12:00
Overview of GMP Manufacturing
Basics of the product life cycle.
12:30
Lunch
13:15
Risk Management Workshop
Practical exploration of risk and mitigation activities.
14:30
QC Laboratories
Activities and practicalities.
15:15
Break
15:30
Compliance
Quality Assurance and Self Inspection.
16:15
Question Time
A chance for questions on the practicalities of GMP.
16:30
Close of Course
Extra Information
Course Material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
Ability for delegates to keep material on a mobile device
Ability to review material at any time pre and post course
Environmental benefits – less paper being used per course Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
CPD Points
7 Points
Development Level
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