This OOS Webinar training will discuss how to handle OOS situations, requirements of ICHQ7A for APIs and how to develop CAPA plans, how to use checklists and forms and how to develop FDA compliant OOS documentation.
Why Should You Attend:
No or inadequate procedures for handling out of specification (OOS) situations, failure investigations and corrective and preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not in line with FDA's expectations or are not followed. Despite of the fact that the FDA has developed a guidance for investigating OOS results, the industry is unsure on what to do. This seminar will demonstrate how requirements for OOS situations in general and specifically requirements of ICH Q7A for APIs will be met. We will discuss how to manage formal and informal investigations in labs and manufacturing. Most recent OOS related FDA 483’s and warning letters will be given examples.
For easy implementation, Attendees will receive:
- SOP: Handling OOS results (updated according to FDA's final OOS guidance)
- SOP; Laboratory Failure Investigations
- SOP: Investigating Manufacturing Incidents
- Checklist: Handling OOS Results
- Case studies: How to Avoid 483s and Warning Letters Related to OOS and Failure Investigations
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
Areas Covered in the seminar:
- FDA and international regulations and guidelines.
- FDA's Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Most recent OOS related FDA 483's and warning letters.
- Requirements of ICH Q7A for APIs.
- Developing an effective SOP for OOS situations and laboratory failure investigations.
- Managing formal and informal investigations in laboratories and manufacturing.
- Efficient use of checklists and forms.
- Compliant handling of retests.
- Retesting: what, when and how many times.
- Developing corrective and preventive action plans.
- Strategies to avoid OOS situations BEFORE they occur.
- FDA compliant documentation of OOS, failures investigations and root causes.
Who will benefit:
- Pharmaceutical and API industry
- Laboratory managers and supervisors
- GMP auditors
- QA/QCU managers and personnel
- Qualified persons (for EU compliance)
- Analysts and other laboratory staff
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .
