2014 ISPE Statistician Forum

Schedule-at-a-Glance

Monday, 31 March

08:30 - 09:00 Welcome & Introductions
Conference Overview:
  • Leader: Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co, USA
    ISPE Statistics in Support of the Lifecycle Approach to Process Validation Forum
  • Leader: Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
09:00 - 09:45 The Status of Implementation of the Lifecycle Approach To PV
09:45 - 10:00 Question/Answer and Discussion
  • Leader: Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
10:00 - 10:30 Networking Break
10:30 - 11:00 Data Needed from PV Stage 1 in Preparation for PV Stages 2 and 3
11:00 - 12:30 Selection and Justification of Number of batches for PPQ
12:30 - 13:30 Lunch
13:30 - 14:00 Number of Batch Discussion and FDA Response
  • Leader: Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
14:00 - 15:30 Sampling and Acceptance Criteria for PPQ
  • Leader: Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
    Sampling Plans Applicable to Product PPQ Activities
  • Leader: Tara Scherder, Managing Director, Arlenda Inc., USA
  • James Bergum, PhD, President, BergumSTATS, LLC, USA
    Blend Uniformity
    ASTM E2709/E2810 method to assess PPQ performance
    ASTM ACCEPTANCE LIMITS FOR CU
  • Rebecca Elliott, Senior Research Scientist, Eli Lilly and Company, USA
    A Statistical Approachto PPQ Acceptance Criteria for Parenteral Drug Products
  • Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
    Sampling Plans Applicable to Product PPQ Activities
15:30 - 16:00 Networking Break
16:00 - 17:00 Predicting Future Performance Part 1:
Process Monitoring Following Stage 2b
  • Leader: Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
    Short Run Statistical Process Control Applicable to Product PPQ Activities
  • Leader: Tara Scherder, Managing Director, Arlenda Inc., USA
  • Bruno Boulanger, CSO, Arlenda, Belgium
    Using a Bayesian Approach to Predict Future Performance
  • Christian Flojgaard, Consultant, NNE Pharmaplan, Denmark
    How many batches...?
  • Mark Johnson, Senior Principal Statistician, Research, AbbVie, USA
    Short Run Statistical Process Control Applicable to Product PPQ Activities
17:00 - 17:30 Discussion and FDA Response
  • Leader: Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
17:30 - 18:30 WELCOME RECEPTION
18:30 - 20:00 Evening Session Discussion Opportunities
Discussion Paper Response
  • Leader: Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co, USA
  • Kurtis Epp, Director, Validation, CSL Behring, Switzerland
    Technical Paper Discussion: Lifecycle Approach to Biotech Process Validation
  • Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
    Technical Discussion Paper: Evaluation of Impact of Statistical Tools on Process Performance Qualification 2 (PPQ) Outcomes

Tuesday, 1 April

08:30 - 08:45 Welcome & Recap & Items for Further Discussion
  • Leader: Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co, USA
    Group 2 Polling Questions
08:45 - 09:45 Predicting Future Performance Part 2:
Planning Stage 3a and Transition to Stage 3b
  • Leader: James Bergum, PhD, President, BergumSTATS, LLC, USA
    Monte Carlo (outputs)
    Transition to Stage 3b: Tiered Approach – ASTM to justify routine testing & sampling
  • Leader: Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
    Control charts and ANOVA
  • James Bergum, PhD, President, BergumSTATS, LLC, USA
    Monte Carlo (outputs)
    Transition to Stage 3b: Tiered Approach – ASTM to justify routine testing & sampling
  • Abe Germansderfer, Sr. Director of Process Development, SHL Group, USA
    Developing Phase 3 Monitoring Ranges
  • Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
    Control charts and ANOVA
  • James Bergum, PhD, President, BergumSTATS, LLC, USA
    Monte Carlo (outputs)
    Transition to Stage 3b: Tiered Approach – ASTM to justify routine testing & sampling
09:45 - 10:15 Stage 3a-3b Discussion and FDA Response
  • Leader: Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
10:15 - 10:45 Networking Break
10:45 - 11:35 Ongoing Process Monitoring
11:35 - 12:00 Ongoing Process Monitoring Discussion and FDA Response
  • Leader: Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, USA
12:00 - 13:00 Lunch
13:00 - 13:45 Regulatory Update on Pharmaceutical Quality Statistics
13:45 - 15:00 Assessing State of Validation and Applying Lifecycle Expectations to Existing/Legacy Products: When to Revalidate
15:00 - 15:30 Networking Break
15:30 - 16:00 Remaining Questions for FDA and Industry Speakers
16:00 - 16:45 Audience Response-Report on Polling Questions
Opportunities for Collaboration
Selection of Topics and Team Members for Best Practice Documents
Future Discussion Forum Planning
    16:45 - 17:00 Wrap-up and Next Steps
    • Leader: Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co, USA
      Group 4 Polling Questions

    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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