 This certification program is intended for those who work in a GLP regulated-environment and are responsible for compliance. Subjects ranging from pre-clinical in-lab requirements through post-approval and manufacturing concerns are covered in detail. Since a solid GLP compliance program can have such a significant impact on efficient, cost-effective drug development and production, personnel with a qualified understanding of these regulations are always in high demand.
Choose three core courses and one elective from the list below. Your elective course should best reflect your area of responsibility within your specific GLP environment:
Core Courses (Choose Three):
- Effective Laboratory Safety Management
- Good Laboratory Practices (GLP) for Pre-Clinical Testing
- Writing Effective Standard Operating Procedures and Other Process Documents
Elective Courses (Choose One):
- Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
- Stability Testing of Proteins and Peptides
- Validation of Computer Systems
- Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
- Writing in the Regulated Environment When English Is Your Second Language
- Introduction to Statistical Analysis of Laboratory Data
- Practical Methods for Project Management
CfPIE can also deliver a customized, on-site GLP certification program to fit your firm's specific needs. For more information on this program, our courses or on-site options, feel free to contact us at +1-610-688-1708 or email us at info@cfpie.com.
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