Presenter: Charles H. Paul
What are Good Manufacturing Practices? They are a set of practices that are required to comply with regulations and industry standards that insure that your products are effective as claimed and are pure and defect free. GMPs minimize the risks associated with processing and manufacturing products. Every country to include the US with the FDA has their own set of governing GMP regulations. Some of these regulations are harmonized with others while some are not. They are not guidelines…they have the weight of law. They essentially dictate how work and the workers executing that work must conduct their work activities. GMPs touch upon virtually every aspect of work life and the processes that are performed as integral components of that work.
GMPs govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished products intended for human use.
The purpose of these regulation? It is very simple – to ensure that medical/medicinal are safe and effective. Achieving this safety and effectiveness requirement however is not so simple. It is achieved by implementing what is known as a Quality System consisting of many regulatory requirements as specified in the governing regulations that must be:
Why You Should Attend:
Why should you attend this webinar and why is it important to you? If you work within regulated medical product industries, almost everything that you do every day is somehow touched by this regulation. Ignorance of the sections of this regulation is no excuse for non-compliance. It takes a complete thorough understanding of the regulation to ensure your compliance to it. This webinar will provide that level of understanding and some basic guidance to assure compliance.
Areas Covered in the Session :
Who Should Attend: