Course Offerings

An overview of Current Good Manufacturing Practices (CGMP) fundamentals used by pharmaceutical and biomanufacturing companies. CGMP exists to protect the health and safety of patients and consumers which supports the mission of the Food and Drug Administration (FDA). This course equips professionals whose responsibilities depend on operating in CGMP and regulated facilities.

Course Objectives

Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.

Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211).

Understand the importance of current Good Documentation Practices (CGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (Electronic Record Keeping).

Recognize the consequences of failing to comply with CGMP.

Outline of instruction

The mission of the FDA

The quality assurance role

Personnel and organization

Buildings and facilities

Equipment

Control of components, drug product containers, and closures

Production and process controls

Packaging and labeling

Holding and distribution

Laboratory controls

Records and reports

Return and salvaged drug products

Complaints and recalls

Good Documentation Practices (GDP)

Computer systems (Part 11)

Regulatory enforcement

CEUs

0.4

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Text and Supplies Needed

Provided by NC BioNetwork

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineers

Specific Industry or Business Support Needs

N/A

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to training Outcomes for Employment

Manufacturing Technicians

Team Leaders and Supervisors

Quality Control Personnel

Quality Assurance Personnel

Maintenance/Engineers

Related Courses

SEF-414CL

SEF-79524

Course Contact Information

Cynthia Lawrence
919-335-1037
[email protected]