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This course will cover essential knowledge, best practice and emerging trends in the validation of manufacturing processes utilised for manufacture of sterile products. Our presenters are internationally recognized as experts in this area. They have extensive experience and their insights and opinions will present attendees with an opportunity to learn first-hand what it really takes to make aseptic process effective and fully compliant with regulatory expectation.

The material presented will provide insight into how regulators and industry are thinking about and approaching aseptic manufacture in the UK and US markets and provide commentary on emerging trends. The presentation style will permit interaction and discussion with the subject matter experts and other present.

It is recommended that participants should be familiar with basic concepts of sterile manufacturing operations prior to attending this course.

Jeanne Moldenhauer is a senior quality assurance/regulatory affairs professional with extensive background in the development and management of a variety of sterilisation and validation processes in the healthcare industry. She has extensive practical background in both manufacturing facilities and corporate operations. Jeanne has a proven track record of successful NDA, sNDA, ANDA, and DMF submissions to FDA. This has included an extensive background in CMC development for drugs, and special expertise in sterile process validation documentation. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. Additionally, she has substantial experience in assessing and validating laboratory and production facilities where solutions were needed for regulatory purposes. She is a Certified Quality Engineer (CQE) and Certified Quality Manager (CQM) (through the American Society for Quality). Jeanne has expertise in utilising information technology to achieve results in quality improvement and cost savings. She is a former Scientific Advisory Board, former Program Advisory Board and former Technical Book Advisory Board member for the Parenteral Drug Association (PDA) and has led Interest Groups for PDA. Jeanne has also served on advisory committees for rapid methods, aseptic processing and sterilisation for FDA. She is a frequent speaker and trainer for a variety of topics within the pharmaceutical and biotechnology industries. She serves on Scientific Advisory Boards for several companies in the area of rapid microbiology.
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Sales Containment. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual Mr. Denk was responsible for in September 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

  • Who should Attend?
    Quality and validation practitioners, engineers, managers and staff involved in the manufacture of sterile medicinal products.
    Technical professionals, management, vendors and operations personnel who support sterile manufacturing operations.
  • Take Back to Your Job
    Understanding of best practice for sterile manufacture and expectations including emerging regulatory views in US and EU.
    An overview of essential factors underpinning successful sterile manufacturing facilities and operations
    An update on current developments in sterile manufacturing generally (including recent ISPE and PDA work in this area)
    Understanding of current regulatory focus and concerns of the TGA.

Thursday8:45am – 9:15amRegistration/Coffee
9:15amWelcome, Introduction and program overview
9:30am – 10:15amSession 1 – Overview of Sterilisation Methods
10:15am – 11:00amSession 2 – Validation of Aseptic Filling Processes
11:15am – 12:00amSession 3 – Validation of Moist Heat Sterilisation Processes
12:00am -12:45pmSession 4 – Validation of Gaseous Sterilisation Processes
12:45pmLunch– Sponsored by Eurofins AMS Laboratories
1:45pm – 2:45pmSession 5 – Validation of Radiation Sterilisation Processes
3:00pm – 4:00pmSession 6 – Validation of Chemical Sterilants
4:00pm – 5:00pmSession 7 – Regulatory Submission of Sterilisation Validation Data
5:00pm – 5:15pm5:15pm – 6:15pmWrap-up, questions and discussion  Networking drinks and Canapés
Friday8:00am – 8:30amRegistration and coffee
8:30am – 8:45amDay one review and Agenda for Day 2
8:45am – 9:30amSession 8 – Introduction on highly potent/toxic or hazardous substances used in the BioTech Industry, Explanation of PDE, OEB and OELs
9:30am – 10:15amSession 9 – Requirements for high potent substances based on occupational hygiene and GMP
10:30am – 11:15amSession 10 – Aseptic Processing and their requirements for high potent substances for different applications like R&D, ADCs, Highly Potent Bios, Cancer Vaccines, Regenerative medicine.
11:15am – 12:00pmSession 11 –Air handling Unit for aseptic processing & Cycle Development/Decontamination Cycle for H2O2
12:00pmLunch – Sponsored by Clean Room Garments
1:00pm – 1:45pmSession 12 – Requirements for high potent aseptic powder processing with different case studies.
1:45pm – 2:30pmSession 13 – TBC
2:45pm – 3:30pmSession 14 – Cleaning Validation requirements for aseptic processing for non-product contact surfaces
3:30pm – 4:15pmSession 15: - Occupational Hygiene Validation on aseptic filling Isolators
4:15pm – 4:30pmWrap up, questions and conclusion
NOTE:Schedule times may be varied during the course with the agreement of delegates to ensure
content is adequately covered.

Victoria Hotel

215 Little Collins Street Melbourne Melbourne 3000, Australia

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Organiser Information

Mandy Bromilow
0447 279 008

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