QC Microbiology
Managing the microbial quality of the product requires a multi faceted approach which includes facility design maintenance and monitoring, microbiological quality of raw materials and exipients, utilities, control process and process equipment, containers closures and the final product's microbial quality. Microrite uses a holistic approach for ensuring the product is not contaminated at any step.
- Total Quality Management of Microbiology
- Microbial Risk Assessment
- Microbiological Contamination Control Programs
- Investigating Microbial Contaminations
- Plant sanitization problem solving
- Selection and qualification/validation of disinfectants
- Environmental monitoring program
- Water monitoring program
- Compressed gases monitoring program
- Compendial testing procedures
- Develop and validate microbiological assays and equipment
- Audit QC microbiology laboratories, contract laboratories and microbiological aspect of manufacturing
- Develop and modify test methods, SOPs, and specifications
- Establish stability programs
- Microbiology training
ON-SITE TRAINING
- Strategy for Investigating Microbial Contaminations
- Cleanroom Microbiology
- Contamination Control
- Environmental Monitoring, Tracking and Trending EM data and compiling meaningful EM Summary Reports
- Disinfectant Qualification and Cleaning Procedures
- Fungal Identification
1:30pm - 3:30pm Eastern Standard Time
1:30pm - 3:30pm Eastern Standard Time
1:30pm - 3:30pm Eastern Standard Time
1:30pm - 3:30pm Eastern Standard Time
September 19th and 20th, 2013
1:30pm - 3:30pm Eastern Standard Time
1:30pm - 3:30pm Eastern Standard Time
May 30th and 31st, 2013
August 7th and 8th, 2013
Call Microrite: (408) 445-0507
1:30pm - 3:30pm Eastern Standard Time
Three Cs for Microrite
C1: Creativity - We believe that creativity, not additional capital, generates the most effective solutions. This is the reason why we use a risk based approach and quality by design approach in all our work.
C2: Communication - We have no secrets and give no surprises. We always will tell you what is happening and teach you everything we know. We communicate!
C3: Cost conscious - We help you succeed by treating your project as our business. Establishing phase specific systems to avoid overkill and overspending is our specialty.
Do it Once...Do it Right!
