FDA ensures the quality of pharmaceuticals in the US marketplace through a system of Good Manufacturing Practices (GMPs), a system it takes very seriously. These GMPs provide a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors.
While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business. EAS Drug GMP Compliance seminar offers an opportunity for a tailored approach, taking these regulations and applying them to your unique manufacturing situation, whether manufacturing an active ingredient or a finished product.
In the EAS Course you will:
- Understand each component within pharmaceutical GMPs and how they can be implemented in your business
- Have an in-depth discussion on how to validate results and calibrate equipment to ensure quality is maintained
- Discuss how to capture and track adverse events reporting
- Develop a checklist to prepare for FDA inspections and 483 Warning Letters