TWO DAY-COURSE
Microbiological Update
From
Jeanne Moldenhauer
Monday
07th and Tuesday 08th February, 2011
09:00-17:00
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
Program:
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!!
