Overview:
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in a given 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 is a course in
Introductory GMP upon employment at a pharmaceutical company, and annual
refresher GMP training.
The goal of this webinar 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:
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 in the Session:
- 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
Who Will Benefit:
- 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)