Advances in Microbiological Testing in Pharmaceutical and Biopharmaceutical Laboratories

A ONE & HALF DAY COMPREHENSIVE AND INTERACTIVE COURSE, CASE STUDIES AND WORKSHOP ON:

- Regulatory basis of microbiological testing
- Review of USP, FDA and EMEA guidelines
- Microbiological Best Lab Practices; USP draft <1117>
- Developing microbiological assays
- Setting up specifications
- Validation of Assays for Sterile Product and Processes
- Raw Material Testing and Quality Strategies
- Using Quality Tools for Microbiological Risk Assessment
- Rapid Microbiological Methods
- Process Analytical Technology (PAT)
- Compatibility Studies

WORKSHOP ON:

Quality in a Microbiology Lab
Critical components and a way to develop a plan for Lab quality improvement:

- FMEA Case Study
- Lab Practices
- Summary/Overview with Q&A

DISTINGUISHED SPEAKERS & MODERATORS

Mr. Donald C. Singer

Dr. Scott Sutton

Who Should Attend?

This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotech, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

- Microbiological testing and release
- Quality Assurance
- Quality Control
- Regulatory and Compliance Personnel
- Documentation and Technical writing
- Validation
- Product Development
- Change Control
- Training
- Materials inspection
- Contract Laboratories
- Consultants
- Clinical Trials and others concerned with productivity and defect reduction effort.
- Technical and quality representatives from supplier companies