Key elements of implementing a Quality System
This course is aimed at staff who are to be involved in implementing a Quality System and managers within the business. The course covers a logical step by step process with key milestones to be achieved during the implementation plan.
An introduction to ISO9001:2000
Staff who are (or will be) responsible for maintaining the Quality System need to understand the basics before they can get to grips with running the system.
An introduction to ISO 13485:2003 & Medical Device Directive 93/42/EEC
This is appropriate to staff working in the Medical Device Manufacturing business who are familiar with ISO9001 but need to develop their knowledge of ISO 13485 or the MDD.
What does a having a Quality System mean to you.
This is suited to staff who have never worked for a business with a quality system before to explain it’s importance. Ideally this is targeted to new members of staff and all staff prior to seeking accreditation.
Internal & External Quality Audits
Internal audits and external supplier audits must be undertaken regularly. They are often neglected so this course looks at their importance and details how to plan, undertake and follow up an audit.
GMP (Good Manufacturing Practice)
Induction for new staff who may not have worked in a cleanroom before and existing cleanroom operators and their supervisors, this course teaches the principals of GMP. Cleanroom do’s and don’ts, understanding the importance of their actions and disciplines all assist in preventing and minimising contamination in your cleanroom both in terms of microbiology and particulates. We keep it simple and give outlines and rules on cleanroom practices and behaviour they will not forget.
Introduction to Microbiology
Ideally delivered in conjunction with GMP training, this course discusses general aspects of microbiology. It explains in simple terms what microorganisms are, how they grow, how they are killed, why they are important, their benefits (yes benefits) and their drawbacks.
Contamination Control
How do we keep our cleanroom clean or in some cases how to we get them clean in the first place. Contamination levels can go up and down so how can we take control and what is acceptable and unacceptable levels.
Laboratory Testing
You diligently send your bioburdens, settle plates, contact plates, water samples and LAL tests to the laboratory for testing, but do you understand what these tests are, how and why they are performed? What should you do with the results? How do you set limits? What do you do with out of specification results?
Sterilisation
Sterility is an absolute, sterile or non-sterile, but in terms of a definition it is in fact a probability a SAL (Sterility Assurance Level). How is an acceptable probability achieved? What do you need to do to ensure sterility of your devices? We explain, in detail, the validation process and requirements for EtO (Ethylene Oxide) and/or gamma irradiation validation.
