Process Development and Validation
Microrite's role in process development and validation includes, but is not limited to, performing process understanding studies in order to establish critical control points, as well as establish process control parameters; perform pre-qualification of the process and subsequently successfully validate the process.
- Establishment of Critical Process Parameters and Controls
- Detailed Process Descriptions
- Process Understanding Studies
- Process Pre-Qualification
- Manufacturing Qualification
- Process Validation Protocols and Reports
- Technology and Design Transfer
- Manufacturing Process Troubleshooting
- Contract Site Selection and Management
- On-Site Manufacturing Support
- Design Change Impact Assessment
- Equipment Cleaning Validations
- Aseptic Process Design and Development
- Production Records Preparation
- Standard Operating Procedures
- 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!
