Wednesday March 13, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the “root cause” of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g., a matter of only several to 40 – 50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the biological laboratory studies that may be required.
The question often arises as why my Company is experiencing these deviations? Very often the answer is simple laboratory errors that require minimal training to correct. In other situations personnel are experiencing difficulties with understanding the USP or the standard operating instructions (SOPs) from which these SOPs are derived. In still other situations, these problems are being caused by management, and personnel require their assistance to minimize these complex periodic issues.
The objective of this live and interactive Executive Conference Corp. (ECC) training webinar is to explore the more common microbiological aspects of data deviation investigations, and how FDA and ICH regulations and guidances impact them. Please plan to bring a cross-functional group to attend this webinar.
By attending, you will learn:
- What are the more common microbiological data deviations.
- How do these deviations occur?
- What solutions exist for minimizing and eliminating these deviations.
- Elements of Deviations, OOS, CAPAs and Risk Management.
- How a deviation becomes an OOS and when a CAPA may be required.
- How the process may be shortened.
- How the use of metrics may provide a “roadmap” for action.
- Why trending of deviations, OOS and CAPAs is important for both the site and during regulatory audits.
- The role of Quality Risk Management and the relationship to microbial data deviation investigations
Personnel from the associated Departments who might benefit from this webinar:
- Microbiology
- Quality Control
- Quality Assurance
- Regulatory Compliance
- Manufacturing
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-095