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.
Keep reading to understand the deliverables of the aseptic manufacturing training.
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.
Keep reading to understand the deliverables of the aseptic manufacturing training.
Course Content
Day 1: Regulatory Requirements, Sterility Assurance & Contamination Control3 Hours | Build the foundation for aseptic processing, sterile dosage forms, and contamination control.
Key Topics
- Introduction to Aseptic Processing & Sterile Dosage Forms
- FDA Guidance, EU GMP Annex 1 (2022), PIC/S & Global Expectations
- Sterility Assurance Principles
- Cleanroom Design, Critical Environments & Personnel Qualification
- Contamination Sources, Cross-Contamination & Endotoxin Control
- Contamination Control Strategy (CCS)
- Environmental Monitoring & Cleaning / Disinfection Programs
Day 2: Process Validation, Investigations & Inspection Readiness
3 Hours | Apply validation, investigation, documentation, and inspection readiness practices.
Key Topics
- Media Fills (Aseptic Process Simulation)
- Smoke Studies & Airflow Visualization
- Sterilization, Equipment Qualification & Process Validation
- Data Integrity & Good Documentation Practices
- Root Cause Analysis (RCA), Deviations & CAPA
- FDA Form 483s, Warning Letters & Regulatory Case Studies
- FDA Inspection Readiness & Industry Best Practices
This agenda is designed for a 6-hour executive seminar and is highly relevant for QA, QC, Manufacturing, Validation, Engineering, Microbiology, and Regulatory Affairs professionals.
Speaker
Dr. Barry A. Friedman - Aseptic Processing & Regulatory Compliance ExpertWho 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
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
- Q/A Session
- Free Handouts on Aseptic Processing of Pharmaceutical and Biotech Products
