Implementing an FDA Compliant Stability Program
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
Future Live Stream Sessions (click to register)
Course Description
Quality assurance studies for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of the stability program are (1) to determine an appropriate and safe stability profile during clinical development and (2) to justify a shelf-life for the product to enter the market for FDA regulatory compliance.
The approach to stability testing and interpretation of stability data has undergone significant change. Strategic international ICH regulatory guidance’s have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from the stability program to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.
Who Should Attend
This 15 hour product shelf life course is designed for directors, managers, supervisors, project planners, analysts, and professional staff seeking to understand, develop or implement a regulatory compliant stability program for their pharmaceutical chemical drug or biologic product. Typical attendees include: Management, Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control, Formulation Development and Analytical Development personnel.
This product shelf life course will help the attendee to design and implement a stability program meeting global stability requirements and expectations. Participants will also become effective in interpretation of stability data.
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™
- (CMWP) Certified Medical Writing Professional™
- (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.