Good Manufacturing Practices (GMP) 101
AGENDA:
DAY 1 (10 AM to 4 PM) Session 1:
| DAY 2 (10 AM to 4 PM) Session 1:
|
About The Course:
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. The goal of this seminar is to enable you to:
- Demonstrate a basic knowledge of GMP requirements
- Interpret these requirements for your day-to-day operations
- Avoid the negative consequences of noncompliance
- Instill a culture of compliance in your organization
The subject of introductory GMP includes a discussion of the pivotal events that have shaped US laws on food, drugs and cosmetics; use of the terms GMP and cGMP (Current Good Manufacturing Practices); key sections in the US Code of Federal Regulations that impact drug manufacture; and how an organization can remain compliant with these regulations in their day-to-day operations.
Why Should You Attend
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.
Areas Covered:
- Food and drug oversight
- Pivotal events that shaped laws in US and scope of FDA actions
- GMP vs. cGMP
- Consequences of noncompliance
- Building a culture of compliance
- Emphasis on education and decision-making
- Training, memory retention, and accountability
- Avoiding over-reliance on metrics
- Recent trends in GMP enforcement and lessons learned
- Course Review and Q&A
Who Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Packaging and Distribution Departments
