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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Attendee Presentations
2018 PDA/FDA Joint Regulatory Conference
Agenda
2018 PDA/FDA Joint Regulatory Conference Program Agenda
(?)
Attendee List
2018 PDA/FDA Joint Regulatory Conference Final Attendee List
(?)
Anna Abram
P1: Taking Stock of the Drug Supply Chain
(?)
Esteban Santos, MS
P1: Taking Stock of the Drug Supply Chain
(?)
Alonza Cruse
P2: The Evolving Regulatory Landscape
(?)
John Lynch, MSc, MPSI
P2: The Evolving Regulatory Landscape
(?)
Janeen Skutnik-Wilkinson
Interest Group 1: Pharmacopoeial
(?)
Rob Cook, PhD
Interest Group 2: Regulatory Affairs
(?)
Ralph Quadflieg, PhD
Interest Group 3: Supply Chain
(?)
Lisa Milano
Interest Group 3: Supply Chain
(?)
Anthony L. Schaff, Sr., P.E.
A1: Combination Products
(?)
CAPT Scott A. Colburn, MS
A1: Combination Products
(?)
Tracy Moore
B1: Aseptic Processing/Annex 1
(?)
Virginia Carroll, PhD
B1: Aseptic Processing/Annex 1
(?)
James M. Fries, MBA
C1: Effective Supplier Quality Audit Programs
(?)
Carmelo Rosa, PsyD
C1: Effective Supplier Quality Audit Programs
(?)
Ronald A. Berk
A2: Aging Facilities and Quality Risk Management
(?)
David L. Chesney
B2: A Successful Journey under Consent Decree
(?)
Brandon Varnau
B2: A Successful Journey under Consent Decree
(?)
Brooke K. Higgins, MS
C2: CMO Oversight: Challenges and Opportunities
(?)
Mary Collins, PhD
C2: CMO Oversight: Challenges and Opportunities
(?)
Natasha Rivas
C2: CMO Oversight: Challenges and Opportunities
(?)
Amanda M. Bishop McFarland, MS
Interest Group 4: Environmental Monitoring/Microbiology and Quality Risk Management
(?)
Shelley Preslar, MBA
Interest Group 5: Facilities and Engineering
(?)
Ralph Quadflieg, PhD
Interest Group 6: Management of Outsourced Operations
(?)
Roger Asselta and John G. Shabushnig
Interest Group 7: Packaging Science and Visual Inspection
(?)
Steven R. Mendivil
Interest Group 8: Quality Systems
(?)
Jennifer M. Gogley
Breakfast 1: Microbiology Issues
(?)
Paul Stinavage, PhD
Breakfast 1: Microbiology Issues
(?)
Donald C. Singer
Breakfast 2: Container Closure Integrity Testing
(?)
Christine Harman, PhD
Breakfast 2: Container Closure Integrity Testing
(?)
Jason A. Rossi, MS
Breakfast 2: Container Closure Integrity Testing
(?)
Marla Stevens-Riley, PhD
Breakfast 2: Container Closure Integrity Testing
(?)
Christopher J. Smalley, PhD
Breakfast 4: 503B Compounding
(?)
Ian F. Deveau, PhD
Breakfast 4: 503B Compounding
(?)
Donald D. Ashley, JD
P3: Compliance Updates
(?)
Carl Fischer, PhD
P3: Compliance Updates
(?)
Martine Hartogensis, DVM
P3: Compliance Updates
(?)
Melissa J. Mendoza
P3: Compliance Updates
(?)
Armando P. Zamora
P3: Compliance Updates
(?)
Ashley B. Boam, MSBE
A3: Product Lifecycle Management and Q12
(?)
Shannon F. Holmes, PhD, RAC
A3: Product Lifecycle Management and Q12
(?)
Kara Follmann, PhD
A3: Product Lifecycle Management and Q12
(?)
Karolyn Gale
A3: Product Lifecycle Management and Q12
(?)
Francis Godwin, MBA
B3: Inspections and Compliance Update
(?)
Maria C. H. Anderson, MS
B3: Inspections and Compliance Update
(?)
Nicholas A. Violand
B3: Inspections and Compliance Update
(?)
Saritza E. Ríos-Solá
C3: Shortage Prevention and Availability: Disaster Recovery Case Studies
(?)
John D. Ayres, MD, JD
Interest Group 9: GMP Links to Pharmacovigilance
(?)
Dipti G. Gulati, PhD and Christopher S. Carter
Interest Group 10: Inspection Trends
(?)
Lindsay Morse
Interest Group 11: Vaccines
(?)
Kenneth D. Hinds, PhD
A4: Process Validation Implementation: Taking Stock, Where are We?
(?)
José E. Meléndez
A4: Process Validation Implementation: Taking Stock, Where are We?
(?)
Commander Tara Gooen Bizjak, MS
B4: Trending for Quality
(?)
Wayne A. Taylor, PhD
B4: Trending for Quality
(?)
Donald B. Ertel
C4: Supply Chain Issues and Innovative Products for Cell and Gene Therapy
(?)
John S. Lunger, MBA
C4: Supply Chain Issues and Innovative Products for Cell and Gene Therapy
(?)
Bo Chi, PhD
A5: Hot Topics in Submissions
(?)
Joan C. Kwong, MS
A5: Hot Topics in Submissions
(?)
Jan Paul Zonnenberg
B5: Quality Systems
(?)
Laura A. Singer
B5: Quality Systems
(?)
Marla A. Phillips, PhD
C5: Ingredient Supplier Oversight
(?)
Ralph Quadflieg, PhD
C5: Ingredient Supplier Oversight
(?)
Michael N. Blackton, MBA
Interest Group 12: Cell and Gene Therapy
(?)
Marsha Steed (Hardiman)
Interest Group 12: Cell and Gene Therapy
(?)
Jacqueline Veivia-Panter
Interest Group 13: Data Integrity
(?)
Jennifer Magnani
Interest Group 14: Quality Systems
(?)
Melissa S. Seymour, MBA
Interest Group 15: Technology Transfer
(?)
Brad Stanard, MPH, PhD
Breakfast 5: Green Chemistry and Product Sustainability
(?)
Tom Polton, MS
Breakfast 5: Green Chemistry and Product Sustainability
(?)
Merle Goddard, MS
Breakfast 6: Evolving Large Volume Parenteral Manufacturing
(?)
Anne Huffman and Anthony Pavell
Breakfast 7: Restricted Access Barrier Systems and Isolators: Current Perspectives
(?)
Stephen E. Langille, PhD
Breakfast 8: Water Systems
(?)
Kristy A. Zielny
Breakfast 9: Training Effectiveness
(?)
CAPT Sean Boyd, MPH
P4: Center Updates
(?)
Peter W. Marks, MD, PhD
P4: Center Updates
(?)
Steven Solomon, DVM, MPH
P4: Center Updates
(?)
Douglas Throckmorton, MD
P4: Center Updates
(?)
Paul Sean Hill
P5: Quality Culture: What’s Holding Us Back?
(?)
Scott C. Nickerson
P5: Quality Culture: What's holding us back?
(?)
Presentations Not Authorized for Distribution
Christopher M. Jones, MBA
C3: Shortage Prevention and Availability: Disaster Recovery Case Studies
Troy Woelfel, MBA
A2: Aging Facilities and Quality Risk Management
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