2012 PDA Innovation & Best Practices on Sterile Technology Conference

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Sterility Assurance for Aseptic Processes and Terminal Sterilization
June 18-19, 2012 | Conrad Chicago | Chicago, Illinois
Exhibition: June 18-19 | Courses: June 20-21

Program Highlights

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Mailed Copy

Attendees receive a FREE copy of PDA TR 22 (Revised 2011)
Process Simulation for Aseptically Filled Products!

Aseptic fill operations and terminal sterilization are considered “special processes” since the output of these processes, product sterility, cannot be fully verified by inspection or testing. Therefore, it is absolutely essential that these processes be properly developed, validated and controlled.

This 2 day conference has been developed to highlight contemporary approaches for sterile product manufacturing using case studies and personal experiences from recognized industry and regulatory agency experts.  

Hear from the FDA at this meeting:

  • John Metcalfe, PhD, Senior Microbiology Review, New Drug Microbiology, CDER, FDA to present on Current Regulatory Review Hot Topics
  • Rebecca Rodriguez, National Drug Expert Investigator, ORA, FDA to speak on Validation of the Aseptic Process and Inspection Trends From a Regulatory Perspective

2012 PDA Innovation & Best Practices on Sterile Technology Conference will bring together all levels of industry professionals to network and benefit from a program that will explore new and improve best practices on sterile technology. 

This 2 day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on process simulation, risk assessment/mitigation, parametric release and post-aseptic fill lethal treatments.  The conference will address topics and concerns related to aseptic processing technologies. Plenary sessions will include presentations by regulatory and industry representatives on topics such as:

  • Aseptic Risk Assessment Modeling Alternatives
  • Regulatory Expectations for Aseptic Processing Submissions
  • Highlights of PDA’s revised TR #22 Process Simulation for Aseptic Processing
  • PDA’s TR # 30: Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat
  • PDA TR# 3: Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
  • Steam In-placed TR 
  • Preservative Systems
  • Formulation Development on Safe Use
  • Coverage of PDAs Position Paper on Post-Aseptic Fill Lethal Treatments
  • Intervention practices in Aseptic Processing
  • Sterility by Design – The newest thinking in aseptic process definition
  • Novel Technologies
  • And much more

The complete program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends.

During the conference, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends.

Learning Objectives

At the completion of this activity, the participant will be able to:

  • Describe the latest methods for aseptic risk evaluation
  • Identify the changes in PDA’s TR #22 – Process Simulation for Aseptic Processing
  • Explain the benefits associated with post-aseptic fill lethal treatments
  • Discuss regulatory risk perspectives and implications for aseptic processing
  • Identify contemporary aseptic processing technologies for risk minimization
  • Give examples of best practices for steam-in-place

Who Should Attend

Departments
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Research and Development | Technical Operations | Validation

Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor

Job Function
Microbiology | Validation | Engineering | Quality | Regulatory | Sterility Assurance | Sterile Operations | Product and Process Development

Contact

Leon D. Lewis
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149
Email: lewis@pda.org

Registration inquiries:


Patresa Day

Manager, Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
Email: day@pda.org

Exhibition inquiries:

David Hall

Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Direct: +1 (240) 688-4405
Email: hall@pda.org

  Before April 6, 2012 April 6 - May 18, 2012 After May 18, 2012
Member $1,295 $1,495 $1,695
Nonmember $1,544 $1,744 $1,944
Government/Health Authority Member $ 700 $ 700 $ 700
Government/Health Authority Nonmember* $ 800 $ 800 $ 800
Academic Member $ 700 $ 700 $ 700
Academic Nonmember* $ 800 $ 800 $ 800
Student Member $ 280 $ 280 $ 280
Student Nonmember* $ 310 $ 310 $ 310

All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.


Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact Patresa Day at day@pda.org for help.


Conrad Chicago
521 North Rush Street
Chicago, IL 60611
Phone: +1 (312) 645-1500
Website: ww.conradhotels.com

Rate: Single: $255.00, plus applicable state and local taxes.

Cut Off Date: Friday, May 11, 2012 (Rooms must be secured by this date in order to receive the PDA rate).

Hotel Accommodations

PDA is excited to host the 2012 PDA Innovation and Best Practices on Sterile Technology Conference at the Conrad Chicago.  A block of rooms have been reserved at the group rate of $255 single or double occupancy, plus applicable state and local taxes. Reservations must be secured by Friday, May 11, 2012, after this date, reservations can be made on a space and rate available basis only.

To make reservations at the Conrad Chicago, please call the Hotel at +1 (312) 645-1500 and reference the 2012 PDA Innovation and Best Practices on Sterile Technology Conference to receive the PDA group rate. Check in time is 3:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 p.m. one day prior to arrival otherwise specified on your reservation information.

Amenities

The Conrad Chicago is located within the Magnificent Mile, allowing guests to be a short walk from the city's most exclusive dining, entertainment, retailers, attractions and entertainment.  Each hotel room is equipped with complimentary wired and wireless internet access.

Travel

Area Airports
Chicago Midway Airport is approximately 13 miles from the hotel and all major carriers service this airport. Chicago-O'Hare International Airport is also serviced by all major carriers and is located approximately 18 miles from the hotel. 

Ground Transportation
Taxi fares from Midway are approximately $25 one way, not including tip, and will take about 20 minutes. One way taxi fares from O'Hare is approximately $45.

Driving
Conrad Chicago is located on North Rush Street between Grand Avenue and Illinois Street.

Metro
Conrad Chicago is located two (2) blocks from the RED line at Jackson .

Hotel Parking
$40 per night Self-Parking (with In & Out Privileges if validated by the front desk)
$ 51 per night Valet Parking (with In & Out Privileges)

2012 PDA Innovation & Best Practices on Sterile Technology Conference will bring together all levels of industry professionals to network and benefit from a program that will explore new and improve best practices on sterile technology. Find new customers, discuss ongoing projects, discover new opportunities, and reconnect with current clients by exhibiting at or sponsoring the industry’s leading conference and exhibition in this dynamic field. Extended, dedicated exhibit hall hours will allow ample time for information exchange with attendees and industry subject matter experts from manufacturing, quality control/assurance, formulation, process development, engineering, validation, and sterile operations. Many high profile, cost-effective sponsorship options are available to help your company increase exposure, build awareness, and stand out from the crowd. Become a sponsor and/or exhibit at the 2012 PDA Innovation & Best Practices on Sterile Technology Conference and strengthen your brand image, increase your visibility, and gain access to hundreds of leaders in the industry.

For exhibition and sponsorship inquiries, please contact:

David Hall
Vice President, Sales
Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
E-mail: hall@pda.org

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