2014 ISPE Statistician Forum

Fees and Registration

How toRegister

Written confirmation will be sent to you after your registration is processed (time permitting).


Conference Fees

Type On or Before
3 Mar
3 Mar
Member US$800 US$1,000
Nonmember US$1,125 US$1,335
Committee US$600 US$600
Government US$500 US$500
Young Professional US$800 US$1,000
Student Member US$200 US$200
Academia Member US$600 US$750


Group Discount Rate

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. To register as a group, please contact ISPE (tel: +1-813-960-2105 ).

Cancellations and Substitutions

Cancellations must be made in writing. If cancellations are received by 10 March 2014, a full refund, minus a 10% handling fee (maximum of $100), will be issued. After that time, no refunds will be granted. If you are unable to attend, substitutions will be accepted. However, nonmembers substituting for a Member must pay difference in fees prior to the start of the event. ISPE is not responsible for lost airfare due to cancellations.



Hotel accommodations and hotel fees are separate from Conference registration fees.

Special Requirements

If you require special accommodations to participate, such as a wheelchair-accessible room or a sign language interpreter, provide a written description with your registration form. Contact ISPE Member Services by tel: +1-813-960-2105 or email ask@ispe.org with questions. Please mark vegetarian, gluten free, or kosher, if needed, in the Special Meal Requirement box on the registration form.

Contact Information

In case we need to contact you regarding event changes, please provide a phone number where you may be reached during non-business hours (either home or cell). Please e-mail this information to ISPE Member Services at ask@ispe.org



ISPE reserves the right to cancel or reschedule any conference and/or to change speakers or instructors. Please be advised that ISPE is not responsible for any airfare/hotel penalties or other travel charges you incur. In case of government intervention or regulation, military activity, strikes or other circumstances that make it impossible for the conference to go ahead at the time and place provided, the participant shall waive any claim for damages or compensation except the amount paid for registration after deduction of actual expenses incurred in connection with the conference. There shall be no future liability on the part of either party.

ISPE Speakers

Speakers selected to present ISPE programmes are leading professionals in their fields. However, it may be necessary to make substitutions. If so, every possible effort will be made to substitute a speaker with comparable qualifications. Agendas are subject to change without notice. Every precaution is taken to ensure accuracy, but ISPE cannot accept responsibility for information distributed or contained in these programmes, or for any other opinion expressed.


Call ISPE Member Services, tel: +1-813-960-2105; email: ask@ispe.org


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?

Indicates content available to ISPE members only.