This comprehensive 2-day course focuses on understanding setting of specifications for the development of drug substances and drug products. This course covers various aspects for setting of specifications including regulatory guidance, statistical considerations, the creation of reasonable and meaningful specifications and the system processes to manage specifications lifecycles in a compliant manner. Participants will gain an understanding of the importance of USP compendial and w.r.t. requirements as it pertains to the setting of specifications and regulations. ICH Q8, Q9, Q10 and the role of QbD in setting specifications as a part of an effective control system also will be addressed. Case studies and examples will be utilized during class to understand basic principles for setting specifications including traditional and statistical approaches.
Upon completion of this course, you will be able to:
- Describe specifications requirements and expectations pertaining to various regulatory bodies (FDA, EMA, ICH)
- Explain the importance of USP’s compendial requirements in specification setting as covered in the USP–NF
- Demonstrate in-depth knowledge of specifications elements their importance throughout the development and lifecycle of a drug substance or product
- Explain ICH Q8, Q9 and Q10 guidance and the role of QbD in setting specifications as a part of effective control strategy
- Apply basic principles for setting specifications including traditional and statistical approaches with various case studies and examples
- Explain and justify effective management of a specifications package according to modules 2.3 and 3 of the common technical document (CTD)
- Describe how to avoid regulatory queries due to ineffective setting of specifications
Who Should Participate?:
- Research & Development
- Quality Assurance
- Quality Control
- Manufacturers
- QA/QC Specialists and Auditors/Compliance
- Regulatory Affairs