This comprehensive course covers fundamental principles, advanced techniques, and regulatory insights necessary for success in aseptic processing. Explore the critical practices and regulatory requirements essential for maintaining sterility and ensuring product quality in pharmaceutical and biotech manufacturing.
To adhere to this demand and raise the benchmark of aseptic manufacturing, we have curated a 2-day long virtual course for esteemed professionals like you. Thus, if you are associated with any department of biological and pharmaceutical manufacturing, this course will upskill your knowledge about every step.
RAPS: This course has been pre-approved by RAPS as eligible for up to 7.0 credits towards a participant's RAC recertification upon full completion.
To adhere to this demand and raise the benchmark of aseptic manufacturing, we have curated a 2-day long virtual course for esteemed professionals like you. Thus, if you are associated with any department of biological and pharmaceutical manufacturing, this course will upskill your knowledge about every step.
RAPS: This course has been pre-approved by RAPS as eligible for up to 7.0 credits towards a participant's RAC recertification upon full completion.
Course Content
- Aseptic Processing - Introduction
- The Disinfected Quantity Form
- Conservation and control of serious surroundings
- Expansion of procedures for process, standardization, Preventive Maintenance, CAPA, etc.
- Exercise of workers to include gowning
- Certification and assessment of variations
- Adulteration Sources in Sterile Manufacturing
- Subdivision Content Controls
- Cross Pollution Hazards
- Cleaning Process and Agents for Sterile Production
- Developing Media Fill Requirements in An Aseptic Environment
- Form FDA 483s
- Equipment set up
- Sterilization process
- Media fills
- Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities)
- Endotoxin sources
Course Provider
Dr. Barry A. Friedman,
Who Should Attend
Aseptic sterile technique training will benefit plenty of individuals such as:- Manufacturing professionals: Get the right knowledge of basic principles and develop skills to control procedure setting
- Project Manager: Understand critical factors required to maintain compliance
- Quality Control Professionals: Decrease the inspections failures, cautionary letters, and agreement rulings
- Reformulation and Formulation Developer: Determine how to develop media fill simulations and work on the worst-case scenarios
- Process Chemistry Specialists: Learn the best repetition techniques for decisive media fill sizes
