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:
Documented in the form of Standard Operating Procedures and Work Instructions
Integrated into the fabric of how the business executes the activities required to place a medical/medicinal product into the marketplace
Be managed on a daily basis to ensure the organization’s compliance to the tenants of the regulation
Be provable when externally audited to verify its effectiveness and compliance with the regulation
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 :
What are the regulations governing Good Manufacturing Practices?
Quality Management
Personnel
Premises and equipment
Documentation
Production
Quality Assurance
Materials management
Production and in-process controls
Packaging and labeling
Storage and distribution
Laboratory controls
Validation
Change control
Rejection and re-use of material
Complaints and recalls
Supplier controls
Who Should Attend:
Research and Development Departments
Quality Assurance Departments
Quality Control Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Packaging Departments
Regulatory Affairs Departments
Logistics Departments
Compliance Departments
Supply Chain Departments
Scientists
Technical Services Staff
Machine Operators and Mechanics