Potent Compounds – A Risk-Based Approach to Reach Quality and Safety Compliance
21-22 September
2011
Evaluate your Containment Systems
and achieve efficient Quality and Safety Compliance without Additional Cost!
Seminar
Leaders:
Richard Denk, Hecht Technologie GmbH (Germany)
Frans Willemsen, Janssen Pharmaceutica NV (Belgium)
How to implement a new high potent or high hazardous product in an existing facility or design a new multi-purpose facility for potent compounds? Where are the critical areas of dust exposure and for product quality? This all and much more will be covered during this interactive two-day Seminar.
The Seminar will examine the latest scientific, risk-based approaches to the containment of potent
compounds. Join a panel discussion with subject matter experts on how to evaluate containment systems and
approaches specifically for potent and highly hazardous substances. What happens when the design/approach
does not work? How do you overcome risk of failure? Be part of this Seminar and get compliant with quality
and safety.
A European regulatory overview will be presented. Get latest trends and insights directly from pharmaceutical
industry professionals and subject matter experts who have successfully implemented containment techniques in
new and /or existing facilities. Real-life workshops, one on Risk Assessment and the other one on Containment
Implementation, will be featured highlights at this Seminar.
With an increasing focus on containment approaches for pharmaceutical manufacturing, Active Pharmaceutical
Ingredients (API) are becoming more targeted, hence more potent and more prolific. Environment, health and
safety (EHS) pressures push for the use of engineering control systems.
RABS and isolation technologies may be an ideal solution for some pharmaceutical manufacturers, but may not
be the most efficient processing solution, nor the most cost effective solution for others. Be part of
workshop exercises and real-life case studies supported by engineering experts that will profile alternative
methods.
Communities of Practice
(COPs):
Active Pharmaceutical Ingredients (API), Containment, Disposables, Good Control Laboratory Practices (GCLP),
Operations Management, Oral Solid Dosage (OSD), Packaging, Process Analytical Technology (PAT),
Process/Product Development (PPD), Project Management (PM), Sustainable Facilities.
Take Back to Your Job:
- Recognise that different types of toxicology limits are set for workers, product and environmental protection
- Recognise or describe the following containment concepts: Contain at source, Containment challenge, Material migration and Risk
- Identify containment technologies and their position in the containment hierarchy
- Recognise applications of hierarchy of containment solutions to real-world containment challenges
- Describe how other industry professionals solved containment challenges
- Understand new technologies available and how they impact containment and cross- contamination
Who Should Attend?
- Engineers, EH&S, Project Management, Product Managers, Purchasers of Containment Equipment, Production Managers and Specialists, Technical Operations, Maintenance, Quality Control and Quality Managers and Specialists, CMOs, Toxicologists.
Related Guidance Documents, Articles, and Publications:
- ISPE Knowledge Brief: Risk–Based Approaches to Cross Contamination
- ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
- ISPE Baseline® Guide Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
- ISPE Baseline® Guide Volume 2: Oral Solid Dosage Forms (Second Edition)
- ISPE Baseline® Guide Volume 1: Active Pharmaceutical Ingredients (Second Edition)
Seminar Content Level: Intermediate
"Delivering Cost Effective GMP Solutions"
Conference Brochurecan be downloaded here (
0 KB).
"Delivering Cost Effective GMP Solutions"
Conference Registration Form can be downloaded here. ( 0 KB)
Latest Agenda:
| Wednesday 21 September 2011 | ||
| 10:00 | 10:15 | Welcome and Introduction Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium) |
| 10:15 | 11:00 | Occupational Health and Safety Considerations for Highly Active Substance
Manufacture
|
| 11:00 | 12:00 | Case Study: Project HCDP. Multipurpose API Facility for high potent products. OEL requirement
<50ng/m3
|
| 12:00 | 13:00 | Lunch and Networking Break |
| 13:00 | 13:45 | Use of flexible Containment Technologies for high potent API’s
|
| 13:45 | 14:30 | Risk Assessment GMP and IH Compliance
|
| 14:30 | 15:00 | Networking Break |
| 15:00 | 17:00 | Workshop Risk Assessment
|
| 17:00 | 17:15 | Summation and Close of Day 1 Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium) |
| 17:30 | 18:30 | Exhibition Networking Reception |
| Thursday 22 September 2011 | ||
| 9:00 | 9:15 | Review of Day 1, Introduction of Day 2 Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium) |
| 9:15 | 10:00 | Controlling exposures to Active Pharmaceutical Ingredients API’s in Chemical
Production
|
| 10:00 | 10:45 | Evaluating the Occupational Hazards of Potent Compounds
|
| 10:45 | 11:15 | Networking Break |
| 11:15 | 12:00 | Clean or dispose? Contained micronisation in Lab Scale
|
| 12:00 | 13:00 | Lunch and Networking Break |
| 13:00 | 13:45 | Overview of the Developments in Containment Technologies in the Pharmaceutical or API
Industry
|
| 13:45 | 14:30 | Assessing the Performance of Contained Dust Collection Systems
|
| 14:30 | 15:15 | Case Study: High containment implementation in existing API manufacturing
|
| 15:15 | 16:45 | Workshop Implementation on Containment
|
| 16:45 | 17:00 | Questions and Answers, Close of Seminar |