Operator-Technician Training
The NCTM’s technical training covers both theory and application of current Good Manufacturing Practices (cGMP) within the pharmaceutical industry, giving new hires a running start and greatly reducing the need for on-the-job training. Our multidisciplinary curriculum offers an in-depth study of upstream and downstream manufacturing processes, sterile environment protocol, bioprocess equipment operations, quality unit operations, documentation practices, and standard operating procedures most common in the pharmaceutical industry.
Introduction to Pharmaceutical Manufacturing
This asynchronous online course comprehensively discusses the fundamental elements associated with the development and manufacture of pharmaceutical products. Training modules discuss the categories of pharmaceutical products, phases of pharmaceutical discovery, development, approval, and varying manufacturing processes (chemical or biological). The curriculum also reviews regulatory agencies and their roles, current Good Manufacturing Practices (cGMP) and GXP, quality assurance and control, and finishes with an exploration of career paths within the pharmaceutical manufacturing industry. 0.2 CEUs
- Module 1: Pharmaceutical manufacturing basics, categories of drugs (small/large molecule), target site, drug substance/drug product, industry sectors, types of manufacturing companies (small, large, CMO)
- Module 2: Introduction to regulations, major legislation, FDA jurisdiction, FDA enforcement, Standards and Guidelines
- Module 3: Stages of the pharmaceutical development process, discovery through IND application, phase I through marketing application, FDA review through surveillance, other licensing applications
- Module 4: Manufacturing process, materials and supplies, materials management, drug production process, upstream processes (large vs. small molecule), downstream processes (large vs. small molecule), equipment, master production record
- Module 5: Current Good Manufacturing Practices (cGMP), quality system requirements, cGMP compliance overview (quality assurance and quality control), basic cleanroom requirements, dressing for cleanrooms, careers in pharmaceutical manufacturing, job skills overview