18 - 19 September 2019, Abu Dhabi, UAE

Day 1

Wednesday: September 18, 2019

08:00  Registration and Refreshments
08:50 Welcome and Opening Remarks from the Chairman

Prof. Gernod Dittel
CEO, Dittel Engineering
08:55 Industry Alerts 
  Diego Bompadre
Instrument Product Manager – Environmental Monitoring and Sales Manager. RIGEL S.r.L.
09:00 ISO Standards in Cleanroom Air Cleanliness for Airborne Particulate Levels 

• Latest guidelines for air cleanliness
• Clean air separation
• Air filtration techniques (Membrane and HEPA)

Koos Agricola
Association of Contamination Control, Netherlands

09:10 Introduction to the Danger of Human Life

• Cancer, Diabetes, TPC, Ebola, BMT
• Personal and environmental safety
• The basics of hygiene

Prof. Gernod Dittel
President, Dittel Engineering

09:50 Design of Buildings for Hazard Laboratories
  • Basics of building construction for hazard labs
• Building requirements for neutralization of bofine material
• Building requirements of highly toxic fluids

Lukas Holzinger
Managing Director, RSE
10:30 Coffee and Networking 
11:00 Shellbe: The Next Generation of Highly Sophisticated Environments

• Shellbe for the use of aseptic/non aseptic technologies
• Shellbe for laboratories and emergencies
• Shellbe for the future of agriculture 

Sanky Marzouk
Business Development Manager, Dittel Engineering

11:40 The Different Types of Processing and Manufacturing of Active Drugs

• General requirments of cleanroom technologies
• Requirments of mini enviroment technologies
• LF (Laminar flow units); BSC ( Bio safety cabinets); Isolatores; RABS (restricted access barrier system); HC ( Hot-Cells)

Matthias Buttazoni
Technical Managing Director, Reinraumtechnik GmbH


HEPA Filters Testing and Cleanrooms Validation 

  • Middle East, where do we stand in reference to the international standards?
• Installation and Periodic Integrity Test
• Cleanroom Validation and Monitoring

Rayan Zakhour
Operations Manager, IGIENAIR Middle East
12:30 Interactive Panel Discussion
13:00 Prayer and Lunch Break
14:00 Cleanroom Classification VS Monitoring

• What is the difference
• ISO guidelines
• Selecting the right instruments

Hasim Solmaz
General Manager - EMEA, Lighthouse Worldwide Solutions

14:30 Mobile Controlled Environments – Advantages and Disadvantages
  • Mobile cleanroom environments concept
• Mobile cleanroom environments advantages and disadvantages
• Mobile cleanroom environments engineering

Samuel Hussain 
Global Sales Manager, MRC
15:00 Regulatory Requirements of Clean Rooms and Air Handling Systems in Pharmaceutical Industry
  • Understanding the regulations for cleanrooms
• What are the design and operational requirements
• Dealing with audits and quality assurance

Sherin Joseph
ASQ Certified Quality Auditor / Pharma Quality Manager / Pharma Industry Expert
15:30 Challenges in Regulatory Standards for State of Art Pharma Manufacturers
  • What are the key points to be considered for Regulatory Standards?
• What exceptional requirement makes Difference in approval system in GCC region?
• Overview of evolution in requirements and guidance in this region?

yed Abid Hassan
ISO Certified Lead Auditor/Regulatory Compliance Head, Jamjoom Pharma
 16:00 Closing Remarks and End of Day 1