PDA Training and Research Institute (TRI)
Courses in Israel


Microbiological Update
From Jeanne Moldenhauer

Monday 07th and Tuesday 08th February, 2011

The David Intercontinental Hotel, Tel Aviv

The Israel Chapter is proud to be able to provide its members with the opportunity to hear Jeanne in Israel and to be able to benefit from her unique store of microbiological knowledge. This is a course that is only available through PDA-TRI and has been developed with Jeanne specifically for the Israel Chapter of PDA. The course will cover the A-Z of microbiology including:

  • Regulatory updates and issues with microbiology laboratories
  • Recent issues with endotoxin
  • Facility design
  • Laboratory planning including running a lean laboratory
  • What are the GMP requirements / expectations for the Microbiology Laboratory
  • Current validation issues in laboratories
  • Microbiology of sterile and non-sterile dosage forms


Day 1 – Monday, February 07, 2011

Time Details Lecturer
08:30 – 09:00 Registration and Coffee
09:00 – 09:15 Opening Introduction PDA Israel Chapter Representative
09:15 – 10:30

Session 1: Regulatory and Compendial Updates

  • Newly issued guidance
  • Pending Guidance
  • Proposed Changes to Compendial Requirements
  • WHO Good Practices

Jeanne Moldenhauer

Karen Ginsbury

10:30 – 11:00 Coffee Break
11:00 – 12:30

Session 2: Environmental Monitoring

  • Establishing a Program
  • Issues with Non-Sterile Manufacturing Processes and Risk Assessment
  • Regulatory Issues with Environmental Monitoring
Jeanne Moldenhauer
12:30 – 13:30 Lunch Break
13:30 – 15:00

Session 3: Laboratory Design and “Lean Labs”

  • Class design project
  • Laboratory design
  • What are Lean Laboratories
  • Incorporating “Lean” into existing laboratories
Jeanne Moldenhauer
15:00 – 15:15 Coffee Break
15:15 – 16:30

Session 4:Sterility Test Investigations

  • Overview of the test
  • Setting up an investigation plan
  • How much testing is enough
  • Product Impact Analysis
  • Special issues with use of rapid sterility test methods
Jeanne Moldenhauer

Day 2 – Tuesday, February 08, 2011

Time Details Lecturer
09:00 – 09:45

Session 5: Endotoxin Methods and Issues

  • Overview of testing
  • Dealing with Interference
  • Dealing with Product Contamination
  • What’s new
Jeanne Moldenhauer
09:45 – 10:30

Session 6: Microbiological Data Deviations

  • Definition
  • Investigation
  • Trending data
  • Product impact assessment

Karen Ginsbury

10:30 – 11:00 Coffee Break
11:00 – 12:30

Session 7: Sterilization Microbiology

  • Biological Requirements for validation from PDA’s TR 1
  • Biological Indicator Selection and Use
Jeanne Moldenhauer
12:30 – 13:30 Lunch Break
13:30 – 15:00

Session 8: Microbiology Support for Validation

  • Use of biological indicators
  • Use of endotoxin challenges
  • Bioburden method required
  • Support of cleaning validation
  • Support of time limitations studies
Jeanne Moldenhauer
15:00 – 15:15 Coffee Break
15:15 – 16:30

Session 9:Media Fill Expectations

  • Requirements for Process Simulations
  • Process Controls
  • Laboratory controls
Jeanne Moldenhauer

Course Director:

Jeanne Moldenhauer

Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. Jeanne is a world renowned expert in Microbiology. She chairs the PDA Environmental Monitoring / Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User’s Group TM, and is a member of ASQ and RAPS. She is the author of Steam Sterilization: A Practitioner’s Guide; Laboratory Validation: A Practitioner’s Guide; Recent Warning Letters: Review for Preparation of an Aseptic Processing Inspectionl and the Editor of Environmental Monitoring a four volume definitive treatise with the 5th volume currently underway among numerous other recent publications. Jeanne is winner of the 2005 PDA / DHI Distinguished Editor / Author Award.

Target Audience:

If you work in the Microbiological or Quality Control Laboratory, Quality Assurance, Aseptic Processing as operations, maintenance or quality personnel you simply cannot afford to miss this course. Contract Laboratories providing microbiological services and contract manufacturers offering aseptic and non-sterile dosage form manufacture will benefit from Jeanne’s in-depth knowledge of microbiology, current regulatory expectations and in particular from her recent specialized analysis of a huge database of FDA warning letters particularly in the area of microbiologically related topics.
Full details will follow shortly.

BONUS: participants will have access to the Isranalytica exhibition where a huge number of exhibitors will be displaying state of the art laboratory equipment and instrumentation!!

http://pdaisrael.co.il/images/back2.gif Participation Fee:
PDA member: 3200 NIS
Non-member: 4200 NIS
(includes PDA membership for one year)

For registration form please click here

Organized & Produced by

Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il