This Pharmaceutical training will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices. The scope of the FDA guidance document on Out-Of-Specification results addresses analytical excursions, not microbiological excursions (Microbiological Data Deviations - MDD), although the approach for correcting them is the same: 1) Determine the root cause 2) Determine a corrective and/or preventative action and 3) Demonstrate that the corrective/preventative action was effective. Recent FDA warning letters cite microbiological excursions and many companies are unsure how to correct them since there are no definitive guidance’s. This webinar will utilize the Aseptic Processing Guidance as a centerpiece for conducting MDD investigations and will supplement its proposals with additional industry-standard best practices.
Areas Covered in the seminar:
- What guidance documents govern microbiological data deviations (MDD).
- What should we do about the specific batch and related batches of products when an MDD is found?
- What is the difference between an objectionable microorganism and one that is pathogenic?
- How do I determine the root cause?
- How do I conduct a microbiological risk assessment?
- How do I determine a corrective and/or preventative action?
- How to I demonstrate that the corrective/preventive action was effective?
- What can I do to minimize the reappearance of the excursion?
Who Will Benefit:
This webinar will provide definitive actions to follow when a microbiological data deviation (MDD) is encountered. It will allow the company to properly disposition its affected product(s) and will provide actions designed to prevent future occurrences. Employees who can benefit include:- Senior Management responsible for making final decisions
- QA directors and managers
- Microbiology analysts and technicians
- Regulatory and Compliance Management
- Consultants
- Quality system auditors
Course Provider
Frank Settineri,
