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 are 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 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.
Disclaimer:
"A GMP assessment can be provided upon request by the company's training department. However, the company would be responsible for managing how the assessment is administered and documented. Neither Compliance4All nor the course trainer, Michael Esposito, will be engaged in the assessment process."
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
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 are 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 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.
Disclaimer:
"A GMP assessment can be provided upon request by the company's training department. However, the company would be responsible for managing how the assessment is administered and documented. Neither Compliance4All nor the course trainer, Michael Esposito, will be engaged in the assessment process."
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 Should Attend
- 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)
