ADVANCED STERILE FACILITIES AND DESIGN

at Novotel on Collins Monday, 19 November 2018 from 8:30 AM - Tuesday, 20 November 2018 to 5:00 PM (AUS Eastern Daylight Time) + Add to calendar19/11/2018 08:3020/11/2018 17:00Australia/SydneyADVANCED STERILE FACILITIES AND DESIGNADVANCED STERILE FACILITIES AND DESIGN Monday, 19 November 2018 from 8:30 AM - Tuesday, 20 November 2018 to 5:00 PM (AUS Eastern Daylight Time) Organiser Mandy Bromilow 0447279008 manager@ispe.org.au Address Novotel on Collins 270 Collins Street Melbourne Melbourne 3000 Australia Event web page: https://www.stickytickets.com.au/77418Novotel on Collins
270 Collins Street
Melbourne Melbourne 3000
AustraliaMandy BromilowfalseDD/MM/YYYY2880

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Event Details

Presenter:

Norm Goldschmidt is President and Sr. Principal at Genesis Engineers. He has over 30 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.

Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.

Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) delegate, Adjunct Professor at the New Jersey Institute of Technology, Lead Author of the ISPE Good Practice Guide for HVAC as well as author, contributor and instructor for ISPE, ASHRAE, David Begg Associates and others. 

Agenda Monday

8:00am – 8:30am Registration and coffee
8:30am – 8:45am Welcome, Introduction and program overview
8:45am – 10:15am Session 1 - The Changing Regulatory Environment
10:15 am Break
10:30am – 12:00pm Session 2 - Evolution of Cleanroom Design Standards and Practices
12:00pm – 1:00pm Lunch – sponsored by Merck
1:00pm – 2:30pm Session 3 - Aseptic Environmental Qualification
2:30 pm Break
2:30pm – 4:45pm Session 4 - Practical Biotech, Sterile and other Cleanroom Optimisation
4:45pm – 5:00pm Wrap-up, questions and discussion
5:00pm – 6:00pm Networking drinks and Canapés sponsored by Clean Room Garments


Agenda Tuesday

8:00am – 8:30am Registration and coffee
8:30am – 8:45am Day one review and Agenda for Day 2
8:45am – 10:15am Session 5 - Non-Sterile Product Space Classification and Issues
10:15 am Break
10:30am – 12:00pm Session 6 - Cross Contamination Prevention
12:00pm Lunch – Sponsored by Eurofins
1:00pm – 2:15pm Session 7 - New Therapies – New Regulations, New Challenges
2:15pm Break
2:15pm – 4:30pm Session 8 - Advances in Aseptic Processing Technology
4:30pm – 4:45pm Wrap up, questions and conclusion

Note: Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered.


Who Should Attend 

  • Quality and validation practitioners, engineers, managers and staff involved in the manufacture of sterile medicinal products.
  • Technical professionals, management, vendors and operations personnel who support sterile manufacturing operations. 

Take Back to Your Job

  • Understanding of best practice for sterile manufacture and expectations including emerging regulatory views in US and EU.
  • An overview of essential factors underpinning successful sterile manufacturing facilities and operations.
  • An update on current developments in sterile manufacturing generally.

ISPE greatly acknowledges the support of our Partners:

   


  

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Location
Novotel on Collins

270 Collins Street Melbourne Melbourne 3000, Australia


(view / directions on google maps)

Organiser Information

Mandy Bromilow
ISPE
0447279008

manager@ispe.org.au