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!!
