Course Description

This five-day workshop offers you a unique opportunity to evaluate several different Rapid Microbiological Systems in a laboratory-based environment. You will hear from  rapid method experts from the US FDA and time will be allotted to "Ask the Inspector" to get your validation, implementation and regulatory questions answered! Hear from users with experience implementing rapid methods at their site!  Other lectures will cover important issues regarding rapid microbial systems such as: comparability protocols, validation, acceptance criteria, and hardware and software considerations. You will also participate in informal discussions with other attendees about the positive and negative attributes of each system related to specific microbiological applications.

Who Should Attend

Departments - Quality Control, Quality Assurance, Manufacturing and Validation

Job Function - Directors, Managers/Supervisors and Auditors 

Take-home Benefits

• Expertise from the FDA regarding specific concerns related to your rapid microbiological program
• Multiple perspectives regarding pros and cons of each system related to specific applications through informal discussions with other participants
• Knowledge to ensure your validation practices cover all aspects, including hardware and software, to be certain your program is ready for regulatory submissions
• First-hand experience evaluating rapid microbial hardware to ensure the system you select is best suited to your application

Key Topics

• Setting acceptance criteria 
• What to expect during an inspection
• "Ask the Inspector"
• Validation of hardware and software for rapid methods
• USP perspective
• Regulatory submission overview

Learning Objectives

Upon completion of this course, participants will be able to:

• Identify various types of rapid microbiological tests that may be routinely performed in a pharmaceutical environment, including validation activities
• Describe at least two key concerns or issues associated with each type of test system
• Relate the regulations and guidelines to the methods associated with rapid microbiology testing
• Manage the pitfalls and difficulties associated with performing the various types of tests on the rapid microbiology systems available
• Recognize the instructions for performing each type of test and what constitutes an appropriate system for their testing
• Create a list of issues and recommendations for these testing methods

Faculty

Jeanne Moldenhauer, Pharma Consultant, Excellent Pharma
Jeanne Moldenhauer is a Pharma Consultant for Excellent Pharma. She has over twenty five years experience in the quality and regulatory aspects of sterile process validation. She has published a book on Steam Sterilization for PDA and served on the task force for the re-write of technical monograph number 1 on steam sterilization.