Education Sessions

E-RC3a, b, & c
Three Successive Sessions
Product Quality Lifecycle Implementation (PQLI):
Design Qualification and Design Review

5 November 13.00 - 17.30
6 November 08.15 -11.30
6 November 14.15 -18.00		 Track: Regulatory / Compliance

ISPE CEUs: 0.5

Help build solutions for our global industry. Take advantage of this special opportunity for all attendees, regulatory and industry leaders to define practical solutions to implementing Q8, Q9 and ultimately Q10.

Leaders from development, manufacturing, quality and engineering will engage with regulatory authorities and trade organizations to turn Q8 and Q9 into a cross-functional and practical reality, helping to shape future thinking and transform our industry. The goal of these particular sessions is to further define areas where industry will be able to provide the technical framework for the implementation of QbD in regulatory submissions. Along with design space, control strategies, and critical vs. non-critical, biotechnology will be introduced as a fourth area of discussion at Annual Meeting. The challenges of legacy products will also be discussed during this PQLI session.

Attendees will have a rare opportunity to hear from regulators plus trade organization representatives from all 3 ICH regions. Regulators from around the world view this critical “next phase” PQLI event as imperative to the success of the industry. Subsequent sessions will follow as concepts are developed from input received worldwide. Compilations will result in technical implementation documents produced by ISPE for industry's use in our worldwide market place.

Take Back to Your Job

  • Discuss critical components of the ICH guidelines
  • Define how issues of design space, control strategies, critical vs. non-critical help refine the application process
  • Discuss biotechnology and legacy products application issues
  • Analyze practical solutions for today to improve practice tomorrow

Who Should Attend

This is a rare opportunity for your views to be heard. Senior leaders to project managers from regulatory, development, quality, and manufacturing who want to facilitate future framing of QbD are encouraged to attend.

Session Leader

Session Speakers

  • Robert Baum, Executive Director, Pfizer Inc
  • Ronald Branning, VP Corporate QA, Gilead Sciences
  • Gail Burnett, Sr Dir, Quality Bioanalytical Dev, Genentech Inc
  • Bruce Davis, Global Capital Director, AstraZeneca
  • Joseph Famulare, Deputy Director, Office of Compliance, CDER, FDA
  • John Groskoph, Director, New Products Group, Pfizer
  • Yukio Hiyama, Section Chief, Drugs Div, National Inst. Health Sciences
  • Steven Kozlowski, Director, Office of Biotechnology, OPS, FDA
  • Jacques Morenas, Assistant Director, AFSSAPS
  • Moheb Nasr, Director, Office of New Drug Quality Assessment, OPS, FDA/CDER/ONDQA
  • Thomas Schultz, Dir, Regulatory Sciences, Johnson & Johnson
  • James Spavins, VP, Global CMC, Pfizer Inc

 

PAT Event Sponsors