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
Dr. Walter Spieler, Roche (Switzerland)

  • Effects of non-uniform high potent category classification system
  • Discrepancies arising between GMP & SHE requirements and possible solutions from a pharmaceutical perspective
  • Experiences from retrofitting facilities - risk assessments and occupational exposure inspections
11:00 12:00

Case Study: Project HCDP. Multipurpose API Facility for high potent products. OEL requirement <50ng/m3
Christoph Doerr, Roche (Switzerland)

  • Design concepts for the multi-purpose plant as an isolated area integrated in an existing production
  • Technical Containment Solutions and Barrier Systems
  • What was good and what should we have made better
12:00 13:00 Lunch and Networking Break
13:00 13:45

Use of flexible Containment Technologies for high potent API’s
Dr. Rainer Nicolai, Roche (Switzerland)

  • Transfer from Centrifuge to Dryer
  • Challenge of using flexible containment system
  • What was good and what should we have made better
13:45 14:30

Risk Assessment GMP and IH Compliance
Richard Denk, Hecht Technologie GmbH (Germany)

  • Quality Assurance and Containment control friend or foe
  • What is important to consider during the Risk Assessment to fulfil the product quality and EH&S
14:30 15:00 Networking Break
15:00 17:00

Workshop Risk Assessment
Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium)

  • Different case studies to work in groups to perform a risk assessment
  • Case studies for API, R&D, pharmaceutical production of potent compounds
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
9:009:15Review of Day 1, Introduction of Day 2
Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium)
9:1510:00

Controlling exposures to Active Pharmaceutical Ingredients API’s in Chemical Production
Michael Vangeel, Janssen Pharmaceutica NV (Belgium)

  • Risk-based Exposure Assessment Process  (RBEAP) model
  • Containment strategy
  • Risk-based Exposure and Assessment Control (RBEAC) Guideline
10:0010:45

Evaluating the Occupational Hazards of Potent Compounds
Justin Mason, Safebridge (UK)

  • Developing a data set for hazard evaluation
  • Qualitative assessments - Assigning occupational health categorisations aka "Control Banding"
  • Quantitative assessments - Determining & setting occupational exposure limits (OEL)
  • Communicating hazards to workers and outside contractors
10:4511:15Networking Break
11:1512:00

Clean or dispose? Contained micronisation in Lab Scale
Olaf Born, Hosokawa  (Germany)

  • Solution for R&D and small scale production
  • Comparison between single and multi-use equipment
  • Cost evaluation
12:0013:00Lunch and Networking Break
13:0013:45

Overview of the Developments in Containment Technologies in the Pharmaceutical or API Industry
Paul O'Brian, PM (Ireland)

  • Containment technologies solutions and equipment for API and pharmaceutical facilities
  • Operations and challenges with the range of available technologies, their application and the performance
13:4514:30

Assessing the Performance of Contained Dust Collection Systems
Alan Sweeney, Camfill (Ireland)

  • What is surrogate testing?
  • Why perform surrogate testing?
  • What impact does surrogate testing have on business?
14:3015:15

Case Study: High containment implementation in existing API manufacturing
Frans Willemsen, Janssen Pharmaceutica NV (Belgium)

  • Containment system selection for an existing API production facility
  • Introducing a new technology in production - Technical challenges
  • Getting the technology embedded into daily operation - Organisation challenges
15:1516:45

Workshop Implementation on Containment
Richard Denk, Hecht Technologie GmbH (Germany); Frans Willemsen, Janssen Pharmaceutica NV (Belgium)

  • Different case studies to work in groups to evaluate different containment solutions
  • Case studies for API, R&D, pharmaceutical production of potent compounds
16:4517:00Questions and Answers, Close of Seminar