This course covers five modules related to Good Manufacturing Practice (GMP).  Topics include:

1. Orientation/Refresher
2. Deliberate Documentation
3. Conducting Investigations
4. QC (Quality Control) Laboratory Operations
5. Management Responsibilities ( for supervisors and managers only)

Upon completion, students will be able to apply these GMP practices in FDA-regulated industries. 

Upon successful completion of this course, participants will:

• Understand the concept of GMP and the critical role these practices play in insuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standards;
• Understand the importance and benefits of a disciplined approach to GMP in an FDA (Food and Drug Administration) regulated environment;
• Understand the concepts of proper documentation, be exposed to the different types of documents and documentation systems utilized in a GMP environment, and be able to avoid some of the pitfalls of unacceptable documenting practices;
• Understand the investigative tools and methodologies that provide a risk-based approach for developing corrective and preventive actions that limit manufacturing failures;
• Understand key principles that insure the validity of quality control systems in the laboratory and how a disciplined approach to meeting the requirements of GMP are beneficial; and
• Understand the critical responsibility that supervision has in assuring GMP compliance and the important role that communication and leadership contribute toward achieving that compliance. 

1. GMP – Orientation/Refresher
“GMP – Orientation/Refresher” provides an introduction to Good Manufacturing Practice (GMP).  GMP regulations require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take a quality approach to ensure that their products are safe, pure, and effective.  The course module stresses the importance and benefits of a disciplined approach to GMP in an FDA (Food and Drug Administration) regulated environment.  Upon successful completion of this module, participants will understand the concept of GMP and the critical role these practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standards.

2. GMP – Deliberate Documentation
“GMP – Deliberate Documentation” provides an overview of the documentation requirements of Good Manufacturing Practice (GMP) and stresses the importance and benefits of a disciplined approach to documentation in an FDA (Food and Drug Administration) regulated environment. 

3. GMP – Conducting Investigations
“GMP – Conducting Investigations” introduces tools utilized in incident investigations and instructs how to properly conduct these investigations in a Good Manufacturing Practice (GMP) environment.

Upon successful completion of this module, participants will understand the investigative tools and methodologies that provide a risk-based approach for developing corrective and preventive actions that limit manufacturing failures.  If the training exercises are included, participants will have sufficient knowledge of Root Cause Analysis (RCA) and Failure Modes and Effects Analysis (FMEA) to be able to put these tools into practice. 

4. GMP – QC Laboratory Operations
“GMP – QC Laboratory Operations” provides a basic introduction to GMP (Good Manufacturing Practice) regulations that apply to laboratories providing quality control (QC) support for manufacturing in an FDA (Food and Drug Administration) regulated industry. 

Upon successful completion of this module, participants will understand key principles that insure the validity of quality control systems in the laboratory and how a disciplined approach to meeting the requirements of GMP are beneficial.

5. GMP – Management Responsibilities
“GMP – Management Responsibilities” communicates the responsibilities of supervisors/managers in a Good Manufacturing Practice (GMP) environment. 

Upon successful completion of this module, participants will understand the critical responsibility that supervision has in assuring GMP compliance and the important role that communication and leadership contribute toward achieving that compliance. 

Visit one of three convenient locations:

• Northern Durham Center (NDC)
• Main Campus – Corporate Education Center (CEC)
• Orange County Skills Development Center, Chapel Hill (OCSDC)

Or

Mail registration with payment to: DTCC, Attn: BioWork and BioPharma Programs, 2401 Snow Hill Road, Durham, NC 27712

Or
Fax registration with credit card information to: 919-686-3519, Attn: BioWork and BioPharma Programs

No. A note book will be provided to students.

No, financial aid is not available for GMP Basics and Related Practices.