Training

 
 
Mr. M S Mahadevan until recently global director of Merck Millipore has been appointed as President & CEO of Biozeen
 
BiOZEEN participated in the recently concluded BANGALORE INDIA BIO 2011 exhibition and was awarded for the best stall design
 
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Training for Industrial Personnel

BiOZEEN is arguably the only organization which provides this unique model of intensive hands on training in a real biotechnology industrial environment coupled with the possibility to learn from industry oriented, well experienced faculties. Operating in a state-of-the-art cGMP compliant pilot plant, it offers the opportunity to improve operational skills but also apprehend new trends and develop managerial expertise.

Industrial training programs are totally a la-carte and custom made to suit the participants requirement.

As an example, below are the sample programs:

Fresh Operators to Experienced Managers Duration: 1 to 8 weeks
cGMP requirement for the Bioprocess Industry
WEEK 1 WEEK 2
Day 1
Media selection
Media preparation
Media sterilization – Fo concept
Day 1
Optimization of centrifugation and tangential flow filtration for broth clarification / bio molecule separation
Day 2
Fermentor functional design
Sterilization In Place of fermentor
Sterilization process validation
Day 2
Cleaning and sanitation of centrifuge and tangential flow filtration systems
Scale up of tangential flow filters

Day 3
Inoculation of fermentor
Maintaining fermentation parameters
Growth kinetics

Day 3
Product sterilization by dead end filtration
Cleaning & sterilization of DE filtration systems
Integrity testing of sterilizing grade filters
Day 4
Scale up / down of fermentation
Optimization of fermentation
Qualification of fermentor
Day 4
Biopharma facility requirements for production
HVAC system
Black & clean utilities
Day 5
Harvest and cleaning in Place
Cleaning process validation
Day 5
Good documentation practices
Visit of the manufacturing center
 
Good Documentation for Validation
Day 1 - Introduction to Validation
Regulatory requirements in the biopharma industry
Quality risk assessment analysis
Introduction to validation master plan
Day 3 & 4 - Process Equipment Qualification
Fermentor qualification
Sterilizer qualification
CIP station qualification
Day 2 - Facility and Utility validation
Facility and building validation
HVAC qualification clean utility systems qualification
Day 5 - Process Validation and GDP
Cleaning validation
Sterilization validation
GDP, OOS and CAPA
 
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