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Scott Bozzone

Scott Bozzone has given numerous presentations from 2011-2016 on topics related to process validation including results from a PDA process validation survey, best practices from a PDA technical report, PDA process validation activities, and the PCMO initiative. He has also taught 2-day PDA TRI process validation training courses from 2012-2015. Additionally, he co-chaired a 2013 PDA/FDA process validation workshop. Prior to 2011, Bozzone presented at conferences on topics such as solid oral dosage forms and powder blending. He has also authored book chapters and articles on subjects including process lifecycle validation and validation of inhalation aerosols.

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List of past presentations- 2011-2016 Podium presentation: Continuous Use of Development Data in Validation Plans and the Process Lifecycle, by Scott Bozzone, PDA Annual Meeting, March 14-16, 2016, San Antonio, Texas Podium presentation: PDA Process Validation Survey- Results by Scott Bozzone, Sept 8-10, 2014, Washington DC. This presentation was summarized and highlighted in the Gold Sheet, October 2014, and later determined to be the biggest story/article of 2014. Process Validation Interest Group presentation European Commissions CGMPs, Draft Annex 15 PDA FDA Joint Regulatory Conference, Washington DC. Sept 8, 2014 Podium presentation: Process Validation: A Technical Report on Best Practices from PDA, PDA Conference with IMB, Dublin Ireland, July 9-10, 2013 (Presentation on PDA TR-60) Podium presentation: PDA Process Validation Activities, PDA Metro Chapter Day. Somerset NJ, April 10, 2013 Process Validation Tutorial Session (1/2 day) by Scott Bozzone, Georgia GMP Conference, Athens Georgia, March 15, 2012 Podium presentation: PCMO Initiative (Paradigm Change in Manufacturing Operations), Process Validation Team, ISPE Conference, Washington DC, June 7, 2011 PDA TRI 2-day PV Training Courses: Oct 1-2, 2015 Washington DC (with Wendy Lambert) April 9-10, 2014 San Antonio, Texas (with Wendy Lambert) July 11-12, 2013 Dublin, Ireland (with Wendy Lambert) Nov 8-9, 2012 Barcelona, Spain (with Wendy Lambert) April 19-20, 2012, Phoenix, Arizona (with Wendy Lambert) PV Workshops PDA FDA Process Validation Workshop, Bethesda Maryland, May 20-21, 2013 (Co-chair with Hal Baseman)
List of past presentations- Prior to 2011 For example: PDA Process Validation Workshops- 2009-2010 (at least 3-4) Istanbul, IKEV Conference, June 2001- Solid Oral Dosage Forms, Powder Blending; Blend Uniformity. Buenos Aires, Argentina IX Congreso Argentino DeFarmacia Y BioQuimica Industrial, June 2002) Publications Book Chapters: - Process Lifecycle Validation (Chapter 8, with Hamid Mollah), in Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by Hamid Mollah, Mike Long and Harold Baseman (editors), Wiley Co. publisher, pp 179-225,2013 - Validation ofInhalation Aerosols (Chapter16) in Pharmaceutical Process Validation,2nd Edition, by Ira Berry & RobertNash (editors), Marcel Dekker publisher, pp 479-528,1993 Articles - Anurag Rathore, Scott Bozzone and A. Hamid Mollah ProcessLifecycle Validation: Applying Risk Management in BioPharm International,Vol 26, Issue 8, Aug. 1, 2013 - K.S. Murthy, Scott Bozzone, and Adel S. Maximos, ProcessValidation of Solid Oral Dosage Forms The officialJournal of ISPE,volume 16, October1996

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Presentations and Publications

  • 1. List of past presentations- 2011-2016 Podium presentation: Continuous Use of Development Data in Validation Plans and the Process Lifecycle, by Scott Bozzone, PDA Annual Meeting, March 14-16, 2016, San Antonio, Texas Podium presentation: PDA Process Validation Survey- Results by Scott Bozzone, Sept 8-10, 2014, Washington DC. This presentation was summarized and highlighted in the Gold Sheet, October 2014, and later determined to be the biggest story/article of 2014. Process Validation Interest Group presentation European Commissions CGMPs, Draft Annex 15 PDA FDA Joint Regulatory Conference, Washington DC. Sept 8, 2014 Podium presentation: Process Validation: A Technical Report on Best Practices from PDA, PDA Conference with IMB, Dublin Ireland, July 9-10, 2013 (Presentation on PDA TR-60) Podium presentation: PDA Process Validation Activities, PDA Metro Chapter Day. Somerset NJ, April 10, 2013 Process Validation Tutorial Session (1/2 day) by Scott Bozzone, Georgia GMP Conference, Athens Georgia, March 15, 2012 Podium presentation: PCMO Initiative (Paradigm Change in Manufacturing Operations), Process Validation Team, ISPE Conference, Washington DC, June 7, 2011 PDA TRI 2-day PV Training Courses: Oct 1-2, 2015 Washington DC (with Wendy Lambert) April 9-10, 2014 San Antonio, Texas (with Wendy Lambert) July 11-12, 2013 Dublin, Ireland (with Wendy Lambert) Nov 8-9, 2012 Barcelona, Spain (with Wendy Lambert) April 19-20, 2012, Phoenix, Arizona (with Wendy Lambert) PV Workshops PDA FDA Process Validation Workshop, Bethesda Maryland, May 20-21, 2013 (Co-chair with Hal Baseman)
  • 2. List of past presentations- Prior to 2011 For example: PDA Process Validation Workshops- 2009-2010 (at least 3-4) Istanbul, IKEV Conference, June 2001- Solid Oral Dosage Forms, Powder Blending; Blend Uniformity. Buenos Aires, Argentina IX Congreso Argentino DeFarmacia Y BioQuimica Industrial, June 2002) Publications Book Chapters: - Process Lifecycle Validation (Chapter 8, with Hamid Mollah), in Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing by Hamid Mollah, Mike Long and Harold Baseman (editors), Wiley Co. publisher, pp 179-225,2013 - Validation ofInhalation Aerosols (Chapter16) in Pharmaceutical Process Validation,2nd Edition, by Ira Berry & RobertNash (editors), Marcel Dekker publisher, pp 479-528,1993 Articles - Anurag Rathore, Scott Bozzone and A. Hamid Mollah ProcessLifecycle Validation: Applying Risk Management in BioPharm International,Vol 26, Issue 8, Aug. 1, 2013 - K.S. Murthy, Scott Bozzone, and Adel S. Maximos, ProcessValidation of Solid Oral Dosage Forms The officialJournal of ISPE,volume 16, October1996