Course Descriptor

This one-day course, provided in collaboration with Lachman Consultants (Ireland), provides an insightful understanding of expectations and successful approaches to implementation of the revised Annex 1. The sessions will focus on aseptic manufacturing compliance, including Annex 1 requirements, developing of implementation strategics, maturity assessment and planning for sustainable improvements.

Taught by highly experienced practitioners, the training will provide exposure to methodology to assess compliance and maturity of the current state.  The course leads the learners through basic principles to more advanced consideration and shares commonly used approaches.  The course will cover key topics related to aseptic manufacture and compliance requirements.

The course will also share recent non-compliance trends and common challenges faced by aseptic manufacturing and provide the opportunity to discuss assessment or implementation challenges.


Key Topics Covered

  • Environment classification and Standards (ISO and Grades A, B and C)
  • Room Qualification (static and dynamic)
  • Aseptic Process Simulation
  • Key elements for Developing a Contamination Control Strategy
  • Opportunity to discuss Industry challenges.

Aseptic Manufacture and Annex 1 with Lachman Consultants

SKU: Biopharma 4.0-2-2 Category:


  • 04/10/2023

    Out of stock

Suitable for:

Operations, Quality Assurance VP, Directors & Snr Mangers / Audit Directors / Corporate Audit teams

Who should attend

Operations, Quality Assurance VP, Directors & Snr Mangers / Audit Directors / Corporate Audit teams

Learning outcomes

  1. Understanding of key considerations and topics related to aseptic manufacturing and related compliance requirement.
  2. Understand potential business risks of lack of sustainable robust processes to meet Annex 1 requirements.
  3. Awareness of Overview of specific requirements and expectations – including for example
    • Principles of Annex 1
    • Pharmaceutical Quality System
    • Premises, equipment, and people including for example;
      • Room classifications and standards (ISO vs. Grade A,B,C)
      • Room qualifications (dynamic vs static testing)
      • People, Process, and equipment Flow diagrams and their use
      • Types of monitoring systems (EMS, BMS and control vs. monitoring)
      • PUPSIT (Pre Use Post Sterilization Integrity testing)
      • Design of Lyophilizer loading / unloading
  4. Production and aseptic technologies
    • RABS and Isolators
    • Other Sterile product manufacturing technologies
  5. Introduction to gap assessments and maturity indicators.
  6. Development of Contamination Control Strategy
  7. Planning for sustainable continuous improvement
  8. Review and discussion of recent Inspection findings / actions trends.

Discover our world class campus facilities