Drug Manufacturing Executive Certification
Qualified CPE Credits: 13.5
This exclusive program introduces the essential aspects of drug manufacturing, including compliance, quality control, and production processes, for both small and large molecule drugs. By successfully completing this industry-recognized Drug Manufacturing Executive Certification, you will not only differentiate yourself but also gain a competitive edge by expanding your career options. To earn your Executive Certification, you must complete eleven Continuing Professional Education (CPE) courses and pass a final exam. Get ahead and stay ahead. Register now!
Course 1: The Biology of Biotech
Provides a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
CPE Credit: 2.0
Course 2: Genetic Engineering Primer
Showcases the use of restriction enzymes and plasmids, molecular tools that offer endless possibilities for research, drug discovery, drug development, and biomanufacturing.
CPE Credit: 1.0
Course 3: Biomanufacturing Primer
Introduces the intricacies driving cell lines, cell banks, upstream/ downstream bioprocessing, and the latest advancements in this dynamic field.
CPE Credit: 1.0
Course 4: Pharmaceutical Manufacturing Primer
Covers essential aspects of small molecule drug production, emphasizing the roles of active pharmaceutical ingredients (API) and excipients.
CPE Credit: 1.0
Five Takeaways
- Develop a comprehensive understanding of DNA, RNA, proteins, restriction enzymes, and plasmids and how these molecules are manipulated to produce medicines.
- State three reasons CMC is critical to patient safety during drug manufacturing.
- Identify the global regulatory bodies that enforce cGMP and familiarize yourself with the laws and publications governing this crucial manufacturing practice.
- Describe the processing steps
for small and large-molecule drugs in detail. - Discuss ways to lower exposure to infectious biologic agents and common bloodborne biohazardous materials through engineering controls.
Course 5: Gene Therapy Manufacturing Primer 101
Ventures into the essential AAV production platforms, comparing four different approaches and dissecting the key elements of the AAV cassette.
CPE Credit: 1.0
Course 6: Gene Therapy Manufacturing Primer 201
Explores in detail the science and regulatory controls of AAV gene therapy manufacturing.
CPE Credit: 1.5
Course 7: cGMP Primer
Enumerates the six requirements for Good Manufacturing Practices, including the Quality Management System (QMS), Premises and Equipment, Personnel Training, Materials Management, Documents and Records, and Validation and Qualification.
CPE Credit: 1.5
Course 8: CMC Primer
Analyzes the significance of CMC across every stage of drug development, from discovery to preclinical to clinical development, ending with post-launch considerations.
CPE Credit: 1.0
Course 9: Biosimilars Primer
Explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products.
CPE Credit: 1.0
Course 10: Laboratory Worker Biosafety Primer
Introduces the WHO biosafety guidelines that keep workers, the environment, and the public safe.
CPE Credit: 1.5
Course 11: OSHA Bloodborne Pathogen Standard Primer
Sets guidelines for employers and employees on safe practices when dealing with potentially infectious materials. The standard covers biosafety levels, personal protective equipment, waste management, and disinfection procedures. Additionally, this primer explains the OSHA Emergency Response Procedures, including spill protocols, emergency response plans, and incident follow-up.
CPE Credit: 1.0
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates