Good Manufacturing Practices (GMP)

Food and drug oversight, Pivotal events that shaped laws in US and scope of FDA actions, GMP vs. cGMP, Consequences of noncompliance, Avoiding over-reliance on metrics, Recent trends in GMP enforcement and lessons learned. This course will be of benefit to anyone whose responsibilities fall under the umbrella of manufacturing, packaging or distribution of pharmaceutical products (e.g., Quality Assurance, Packaging, Operations, Planning).

The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market. It is expected that all employees who are involved in pharmaceutical production will attend GMP-related training on a regular basis.