Good Manufacturing Practices (GMP) 101

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 YOU SHOULD ATTEND		WHO SHOULD 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.		Quality Assurance Departments Regulatory Affairs Departments Manufacturing Departments Engineering Departments Operations Departments Production Departments Packaging and Distribution Departments

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

AGENDA

DAY 1 (10 AM to 4 PM)
Session 1:

Seminar objectives review, expectations and scope
Interview attendees regarding their specific responsibilities and needs
Agreement on focus

Session 2:

Food and drug oversight
Pivotal events that shaped laws in US and scope of FDA actions
Examples of issues and regulations that they apply to

Session 3:

Regulatory requirements for GMPs:
- Quality Assurance
- Training
- Documentation
- Laboratory Requirements
- Facilities
- Packaging and Labeling

Session 4:

Consequences of noncompliance (including recent examples)
Building a culture of compliance
Review, Q&A

DAY 2 (10 AM to 4 PM)
Session 1:

Seminar objectives review, expectations and scope
Interview attendees regarding their specific responsibilities and needs
Agreement on focus

Session 2:

GMP vs. cGMP
Compounding Facilities

Session 3:

Emphasis on education and decision-making
Training, memory retention, and accountability
Notes on substandard product

Session 4:

Onboarding new employees:
Notes on Orientation
Introductory GMP Training
Curriculum Assignments

Session 5:

Summary, Q&A, Knowledge check