Out of Specification (OOS) Investigations: Advanced Training for Pharmaceutical QA
Gstudy > Courses and seminars > Out of Specification (OOS) Investigations: Advanced Training for Pharmaceutical QA
Jul 8, 2025
By Jenny Sverdlova B.Sc.
1.0
Quality Assurance
Audits
Location: Frontal
Starts at: 09:30
Duration: 1 Session
Language: Hebrew
Transform Your Out-of-Specification (OOS) Investigation Approach with Expert-Led Training
Join our comprehensive seminar designed to elevate your Out-of-Specification investigation capabilities. This intensive session combines regulatory guidance review, real-world inspection insights, and advanced investigative methodologies to enhance your pharmaceutical quality assurance expertise.
Key Learning Outcomes
- Master current FDA and MHRA guidance requirements for OOS investigations
- Understand expectations from recent regulatory inspections
- Apply best practices aligned with global pharmaceutical standards
- Analyze findings from recent FDA and Ministry of Health inspections
- Identify critical "hot topics" impacting industry compliance
- Develop strategic approaches to complex investigation scenarios
- Engage in interactive brainstorming sessions with industry specialists
- Gain access to proven investigative thinking methodologies
- Build practical skills through case-study analysis
Beneficial for professionals who:
- Conduct or oversee OOS investigations
- Review investigation reports and CAPA plans
- Interface with regulatory authorities
- Seek enhanced investigative problem-solving capabilities
Why Attend This Seminar?
- Refresh your understanding of current regulatory expectations
- Access confidential insights from recent inspection outcomes
- Network with industry experts and peers
- Receive practical tools for immediate implementation
Featured Guidance Documents:
- FDA Guidance: "Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production" (May 2022)
- MHRA Guidance: "Out of Specification & Out of Trend Investigations" (October 2017)
About Jenny Sverdlova B.Sc.
Jenny Sverdlova - Quality and Laboratory Expert Over 15 years of pharmaceutical quality experience across analytical laboratories, quality assurance, and regulatory compliance. Expert in laboratory investigations, audit management, and quality system implementation. Education: B.Sc. Chemistry, Ben Gurion University
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