 The FDA's regulations on Current Good Manufacturing Practices (cGMP) affect many different phases of pharmaceutical, biologic and biopharmaceutical development. As a result, CfPIE has developed a certification program to meet the educational needs of those responsible for compliance with this complex regulation. This track is for any individual accountable for any aspect of cGMP compliance. Our industry experts have developed the core and elective components of this program to give participants in-depth knowledge of cGMP regulations - from clinical development through post-approval drug and biotech product manufacture. Each course is designed to present and explain cGMP mandates, as well as to provide comprehensive analysis and instruction on how to best comply.
Select any three core courses from the list below and one elective course that best fits your individual set of responsibilities:
Core Courses (Choose Three):
- Good Manufacturing Practices (cGMP)
- cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
- Validation of Computer Systems
- Reporting Failure Investigations and Process Deviations
- Process Validation for Drugs and Biologics
Elective Courses (Choose One):
- Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
- FDA Inspections: What To Expect And How To Prepare
- Stability Programs for Product Shelf Life - From Development to Approval
- Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries
- Practical Methods for Project Management
- Project Management for Phase 1 & 2 Clinical Trials
- Writing Effective Standard Operating Procedures and Other Process Documents
- Effective Quality Assurance Auditing for FDA Regulated Industries
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
- Pharmaceutical, Biopharmaceutical, and Biologics Quality Control Laboratories: A Regulatory Compliance Primer
- Root Cause Analysis for CAPA
- Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
- Pharmaceutical Production Batch Record Review
Please contact CfPIE at +1-610-688-1708 or via email info@cfpie.com
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