Track 3

 

ASEPTIC PROCESSING AND STERILE MANUFACTURING WORKSHOP

OVERVIEW
Aseptic Processing and Sterile Manufacturing workshop will deliberate on technological advancements and key innovations in aseptic processing and sterilization processes.
KEY OBJECTIVES
  • Regulatory Update and Best Practices
  • Risk Management for Sterile Manufacturing
  • Environmental Monitoring - Compliant and Reasonable
  • Handling Failures in Sterile Manufacturing
  • Single-use Technology
TRAINER

Dr. Olivier Chancel

Sterility and Aseptic Practices Expert and Senior Quality Auditor

Boehringer Ingelheim

DAY 1
08:00 REGISTRATIONS
09:00 Plenary Session
NETWORKING BREAK
11:30 Cross-Disciplinary Perspectives on Innovative Containment Strategies, Aseptic Processing and Sterile Manufacturing
  • What’s the best approach to potent compound containment?
  • Current approaches, benefits and limitations
  • Handling Failures and risks in aseptic processing sterile manufacturing
  • New approaches like clean room technologies and single-use manufacturing
Sai Sethuraman,
Head - Product and Portfolio Development (India), Global Parenteral Product Development,
Pfizer
12:30 Impact of Pharma Environment and Water Quality on Formulation
Ramanuj Samal,
Field Marketing Manager,
Beckman Coulter India Pvt. Ltd.
LUNCH & NETWORKING
14:00 Principles of Sterilization and Disinfection
  • Different types of sterilization
  • Heat: Dry and Steam
  • Filtration and radiation
Dr. Tarun Chugh, Consultant, Simco Consultancy
15:00 Analysing Different Facility Designs for Sterile Product Manufacturing
  • Grades of clean areas
  • Different HEPAs and airflows for aseptic processing
  • Restricted access barrier systems and isolators
  • Cleanroom technology
Dr. Tarun Chugh, Consultant, Simco Consultancy
HIGH-TEA & NETWORKING
16:30 Challenges of Visual Inspection
  • Visual Inspection Overview
  • Regulatory requirement’s
  • Visual Inspection Life Cycle
  • Inspection Process flow
  • Interpretation of Inspection Results
  • Inspection Method and Technology
  • Qualification and validation of Inspection process
  • Recent FDA 483 Observations
  • Recent FDA Warning Letters
  • Recent FDA Recalls
  • Case Studies
  • Q&A
Amit Mishra, Manager, Slayback Pharma
17:30 CLOSING REMARKS
END OF DAY 1

 

DAY 2
08:00 REGISTRATIONS
09:30 Opening Remarks
09:45 Regulatory Standards and Current Updates
  • New EU annex 1: Main changes
  • Comparison with the last version
Dr. Olivier Chancel,
Sterility and Aseptic Practices Expert and Senior Quality Auditor,
Boehringer Ingelheim
10:45 Environmental Monitoring
  • Non-viable particle monitoring
  • How to manage excursions
  • Focus on alternative approaches of the recent ISO 14644-2
Dr. Olivier Chancel,
Sterility and Aseptic Practices Expert and Senior Quality Auditor,
Boehringer Ingelheim
NETWORKING BREAK
12:00 Environmental Monitoring (continuation)
  • Non-viable particle monitoring
  • How to manage excursions
  • Focus on alternative approaches of the recent ISO 14644-2
Dr. Olivier Chancel,
Sterility and Aseptic Practices Expert and Senior Quality Auditor,
Boehringer Ingelheim
12:30 Process Simulations for Aseptic Processing
  • Design and Execution
  • Limits of Media Fill Tests
  • Case Studies
Dr. Olivier Chancel,
Sterility and Aseptic Practices Expert and Senior Quality Auditor,
Boehringer Ingelheim
LUNCH & NETWORKING
15:00 Preventive Management: Contamination, Microbiology and Disinfection
  • Series of some short real life case studies
  • Handling Failures: Detailed investigation on water for injection
Dr. Olivier Chancel,
Sterility and Aseptic Practices Expert and Senior Quality Auditor,
Boehringer Ingelheim
16:30 CLOSING REMARKS FOLLOWED BY HIGH-TEA & NETWORKING
END OF DAY 2

for detailed agenda download the brochure