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 utilizing 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%20Denk.png 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.

A Representative from the TGA Office of Manufacturing Quality will provide a presentation trends in observations and issues they have observed in inspections of GMP regulated manufacturer of sterile medicines both in Australia and overseas.  TGA will also participate in a facilitated panel discussion with the presenters on topics of interest from delegates at the event.


This course will cover essential knowledge, best practice and emerging trends in the validation of manufacturing processes utilized 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.

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.

When: Thursday 16th & Friday 17th November 2017

Where: Ibis Styles Hotel The Victoria
215 Little Collins Street
Melbourne, Victoria



8:45am – 9:15am



Welcome, Introduction and program overview

9:30am – 10:15am

Session 1 – Overview of Sterilisation Methods

10:15am – 11:00am

Session 2 – Validation of Aseptic Filling Processes



11:15am – 12:00am

Session 3 – Validation of Moist Heat Sterilisation Processes

12:00am -12:45pm

Session 4 – Validation of Gaseous Sterilisation Processes


Lunch– Sponsored by Eurofins AMS Laboratories

1:45pm – 2:45pm

Session 5 – Validation of Radiation Sterilisation Processes



3:00pm – 4:00pm

Session 6 – Validation of Chemical Sterilants

4:00pm – 5:00pm

Session 7 – Regulatory Submission of Sterilisation Validation Data

5:00pm – 5:15pm

5:15pm – 6:15pm

Wrap-up, questions and discussion

Networking drinks and Canapés



8:00am – 8:30am



Registration and coffee


8:30am – 8:45am

Day one review and Agenda for Day 2


8:45am – 9:30am

Session 8Introduction on highly potent/toxic or hazardous substances used in the BioTech Industry, Explanation of PDE, OEB and OELs


9:30am – 10:15am

Session 9 Requirements for high potent substances based on occupational hygiene and GMP





10:30am – 11:15am

Session 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 – 12:00pm

Session 11 Air handling Unit for aseptic processing & Cycle Development/Decontamination Cycle for H2O2



Lunch – Sponsored by Clean Room Garments


1:00pm – 1:45pm

Session 12 – Requirements for high potent aseptic powder processing with different case studies.


1:45pm – 2:30pm

Session 13TGA perspectives on Validation of sterile processes





2:45pm – 3:30pm

Session 14Cleaning Validation requirements for aseptic processing for non-product contact surfaces


3:30pm – 4:15pm

Session 15: - Occupational Hygiene Validation on aseptic filling Isolators


4:15pm – 4:30pm

Wrap up, questions and conclusion

Note** Schedule times may be varied during the course with the agreement of delegates to ensure
content is adequately covered.



ISPE/PDA Member: Early Bird $850 incl GST Standard $1050 incl GST-

Non member: Early Bird $1100 incl GST Standard $1300 incl GST

Registration fee includes all day catering and course material (supplied electronically).

Early Bird Rate available until 24 Oct 2017







Click here to book online



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