2014 ISPE Statistician Forum

Hotel and Area Information

Conference Hotel

Westin Philadelphia
99 South 17th Street
Philadelphia, PA 19103
Hotel Website

Check in: 15.00
Check out: 12.00

Reservations

Call the Westin Philadelphia tel: +1-215-563-1600 to make reservations.  The current rate is $344.

Parking

Valet parking daily rate is US$40 and overnight US$51. Self-parking daily rate is US$30 and overnight US$36.

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Airport Information

  • Philadelphia International Airport (PHL)
  • Travel Distance: Approximately 4.35 miles/7.0 km

Transportation

Type Typical Minimum Charge Description
Limousine US$35.00  
Lady Liberty US$10.00 5:30am-12:30am. Approximate cost is US$10 one way. Check in at Ground Transportation. Reservations are recommended for departure back to the airport. Hotel Concierge can assist or call 1-215-724-8888.
Rental Car Rates Vary  
Taxi from the airport US$28.50 A flat fee of US$28.50 to anywhere in Center City plus US$1 extra per person.
Taxi from the 30th Street Train Station US$7.00 Approximately US$7.
Regional Rail Airport Line US$8.00 runs from the Airport to Suburban Train Station located at 16th & JFK and is then a block and a half walk to the hotel. This public train service, Regional Rail Airport Line, runs from 4:30am until 12:30am daily every half hour on the hour. The cost is US$8 weekdays and US$7 evenings and weekends.

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Weather and What to Wear

Meeting delegates are encouraged to dress business casual. The temperatures in March/April range from highs of 58°F/14°C and lows of 39°F/4°C. Temperatures in meeting rooms tend to be mild, a light sweater or jacket would be recommended. For current weather information, check weather.com.

Conference Handouts

Handouts Now Available »

Attendee Roster Now Available » locked to attendees only


Explore Answers to These Questions!

  • Are you applying the right statistical approaches to Process Validation? What misapplications of statistics have been observed by FDA?
  • Why is the FDA guidance on blend uniformity being withdrawn? What is your opinion regarding impact to current and future product development efforts?
  • How will you handle tightened expectations regarding USP or ICH UDU criteria?
  • Do you know if the expectations are similar with regard to statistical sampling and acceptance criteria for small and large molecule products?
  • When does a validation fail? What level of confidence /coverage/ acceptance criteria must be met to continue to make and release batches?
  • What historical data such as CQA variability should drive decisions regarding revalidation?
  • Are you using best practices for applying risk assessment, science, variability and statistics to determine the number of PPQ batches?
  • Do you know the role of input variability in determining readiness for PV?
  • When do you think it is appropriate to apply statistical methods to process input parameters?
  • Should you apply statistical justification of routine sampling and testing to all dosage forms and API?
  • What statistical signals would you utilize to determine the need for remediation?
  • In addition to Critical Quality Attributes, are there other areas of the process appropriate you should use for monitoring statistical methods? Which statistical methods are appropriate?

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