Upcoming Topic

1. Validation of Moist Heat Sterilization Processes

Upon completion of this course you will be able to:

·         Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program

·         Develop a decision tree to select the most appropriate sterilization process based on the attributes of the load type

·         Utilize the Semilog Survivor Curve Equation in support of the development and ongoing control of the sterilization program

·         Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types

·         List the critical elements of process performance qualification

2. Training Courses Environmental Monitoring

Overview

Environmental monitoring in clean rooms

General aspects of contamination in pharmaceutical industry (microbial contamination and cross contamination, different microorganisms, origins, impact…)

Regulatory aspects  of environmental monitoring (ISO, FDA/USP, EU and WHO). 

·         General principles for the microbial contamination control 

·         Definition of control plan and validation

·         Sampling techniques and results analysis

·         Cleaning validation and decontamination 

·         Rapid alternative microbiological methods

·         Frequent mistakes observed during inspections or audits

·         Limits of microbiological methods (VBNC, anaerobes, sampling techniques)

   3. Dedicated or Shared Facilities? A Risk-Based Approach

Overview

·         Using a case study, this hands-on one day course will allow participants to perform a risk assessment, using principles from ICH Q9 Quality Risk Management integrated with PDAs Technical Report No 54 QRM for Biopharmaceuticals:
Highly potent / spore-formers / cytotoxic / other APIs and intermediates
 Product and Process Mapping
URS

·         Facility Design / Decision making based on risk assessment

·         HVAC design, and sink or bubble for pressurization

·         Airlocks and clean / dirty corridors

·         Other technical and organizational measures

The course will integrate GMP requirements from ICH Q7 and Annex 2 of the EU GMPs on Manufacture of Biological Active Substance as well as the draft EU revisions to Chapters 3 (Facilities and Equipment) and 5 (Production) and the Health-Based Exposure Limits Guidance.

4. Trends in Aseptic Manufacturing

Management and organizational aspects of facilities, technologies and equipment, and  regulatory developments. The focus of the technical part will be on implementation and practical experiences of single use systems in manufacturing environments covering facility design, formulation, fill finish operations and e.g. aspects of sterility assurance and handling. A case study describes a new facility for biotech products with single use technologies and ready to use components. A full session is dedicated to supportive activities of manufacturing like maintenance, cleaning, decontamination, monitoring, intervention handling and documentation. In the regulatory session two presentations from the AIFA and EMA will update the audience on inspection trends and upcoming new guidelines from the EMA. The impact of recent guidelines on manufacturing will be discussed from an industry perspective.

There will be plenty of time for discussions during the meeting. In addition there will be a site visit of the IMA life manufacturing plant and a vendor’s exhibition.

5. Environmental Monitoring

Environmental monitoring in clean rooms

General aspects of contamination in pharmaceutical industry (microbial contamination and cross contamination, different microorganisms, origins, impact…)

·         Regulatory aspects of environmental monitoring (ISO, FDA/USP, EU and WHO)

·         General principles for the microbial contamination control 

·         Definition of control plan and validation

·         Sampling techniques and results analysis

·         Cleaning validation and decontamination 

·         Rapid alternative microbiological methods

·         Frequent mistakes observed during inspections or audits

·         Limits of microbiological methods (VBNC, anaerobes, sampling techniques)

Topic on request:
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