Introduction to Good Manufacturing Practice (GMP) presents the principles and fundamental requirements for GMP compliance. It will help participants understand their role within the quality system at their company and make GMP part of their daily routine. This course is catered for GMP regulated industries such as pharmaceutical, food, skincare or healthcare industries.
UPON COMPLETION OF THIS WORKSHOP, PARTICIPANTS WOULD BE ABLE TO:
- Understand the importance & principles of GMP regulation.
- Have an increased awareness of their personal role within the GMP system.
- Be equipped to improve the existing GMP system at their workplace.
- Be able to conduct a self-audit of GMP compliance.
WHO SHOULD ATTEND:
- Employees within a GMP regulated industry or those expected to enter one.
- Employees whom have been given new responsibilities within a GMP regulated industry.
- Persons in charge of supervising/managing the GMP quality system.
COURSE OUTLINE: 2 DAYS
1. What is Quality?
- Why should an organisation interested in quality?
2. Why GMP?
- What can you do?
- Other Good Practices: GSP, GLP, GCP
3. Quality Management
- Quality Assurance, Quality Control & GMP
Function and responsibilities
4. GMP Guidelines
- Regulatory agencies
5. Importance of Documentation (part1)
- Importance of Documentation (part2)
6. Basic Components of GMP
- Premises (Design, Layout, Construction )
- Equipment (Design & Construction, Location, Calibration)
- Sanitation & Hygiene (Cleaning Principle, Personnel Hygiene, Sanitation Premises & Equipment)
- Personnel (Qualified, Sufficient in number, Training )
- Material (Different Type,Specification )
- Storage (GSP) Contract Manufacturing & Analysis
- Complaints & Recall
- The Importance of Self-Audit
- Scope of Audit
Lectures will be complemented with group discussions, role-play, simulation, questions and answer. All the topics comes with either a quiz or exercises.
You can choose whether you would like to attend one of our scheduled public courses or have it delivered on your premises as an in-company solution
Contact: firstname.lastname@example.org for more information
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