Out of Specification (OOS) Investigations: Advanced Training for Pharmaceutical QA – Coming Soon

Transform Your Out-of-Specification (OOS) Investigation Approach with Expert-Led Training

This comprehensive seminar is designed to strengthen Out-of-Specification investigation capabilities through regulatory guidance, real-world inspection insights and advanced investigative methodologies.

Participants will review current regulatory expectations, analyze recent inspection findings and develop practical approaches to complex pharmaceutical quality investigations.

Course Details

Hours: 09:30–13:00
Format: Online
Availability: In-house training for company teams
Dates: Coordinated in advance with the requesting organization

Alternatively, participants may register for the waiting list for a future open course.

Key Learning Outcomes

• Master current FDA and MHRA guidance requirements for OOS investigations
• Understand expectations arising from recent regulatory inspections
• Apply best practices aligned with global pharmaceutical standards
• Analyze findings from recent FDA and Ministry of Health inspections
• Identify critical industry compliance topics
• Develop strategic approaches to complex investigation scenarios
• Participate in interactive brainstorming sessions with industry specialists
• Gain access to proven investigative thinking methodologies
• Build practical skills through case-study analysis

Who Should Attend?

Professionals who:

• Conduct or oversee OOS investigations
• Review investigation reports and CAPA plans
• Interface with regulatory authorities
• Seek to strengthen their 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

Registration Information

The course is available as an in-house training program for company teams, on dates to be coordinated in advance.

Alternatively, participants may register for the waiting list for an open course.

Opening of the course is subject to a minimum registration of six participants. Once a suitable group is formed, registered participants will be contacted to confirm the course date and complete the registration process.

Registration for the waiting list does not constitute final confirmation that the course will open. The course date will be determined and communicated once the minimum number of participants has been reached.