Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Brazil Chapter Visual Inspection Event

Nov 07 - Nov 09, 2017 |
Nov 09, 2017 |
Hotel Century Paulista | Paraíso, São Paulo
  • Chapter
  • Western Hemisphere Events
Add event to: ICal Outlook Google Calendar

November 7-9, 2017, Hotel Century Paulista, Sao Paulo, Brazil

The event features:

  • Training available for 50 attendees
  • Exhibition area for Visual Inspection products and services
  • Simultaneous translation
  • Contact registration: eventos@pdabrazil.org or Phone 11-2894-9730/31

View the event flyer here.

Agenda

November 7 & 8

  • Introduction
  • Why We Inspect
  • Risk Assessment
  • Regulatory Requirements FDA/EMA/other standards
  • Critical parameters - Lighting, Duration/Speed, Contrast, Movement
  • Inspection Methods and Technologies: Manual, Semi-automated and Automated Visual Inspection
  • Laboratory Demonstration: Station Set-up, Light Measurement and Manual Visual Inspection Technique
  • Defect Classification Strategies
  • Acceptance Sampling
  • Analyzing Inspection Results
  • Inspector Selection and Qualification: Vision Screening, Initial Training, Initial Qualification and Requalification
  • Inspection Strategies: Re-inspection, 2-Stage Inspection, Focused Inspection and Empty Vial Inspection
  • Inspection Validation Methods: Comparing and Acceptance Criteria

November 9

  • PDA Global Visual Inspection Survey
  • PDA Brazilian Visual Inspection Survey
  • PDA Visual Inspection Tecnology benchmarking
  • Visual inspection Forum
  • Sponsors Presentations

Registration

PDA members US$560, R$1.800,00
Non-member US$610, R$1.950,00

Speaker

John G. Shabushnig, Ph.D. is the founder of Insight Pharma Consulting, providing expert guidance in all aspects of visual inspection. He has over 30 years of industry experience including Sr. Manager/Team Leader in Pfizer's Global Quality Operations where he was responsible for providing microbiology and aseptic manufacturing technical support. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology (PAT) and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering and automation and was promoted to the position of Business Unit Director of the Center for Advanced Sterile Technology (CAST). He is a co-author of the recently published book Visual Inspection and Particulate Control. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association (PDA), having served on the Board of Directors. John serves on the United States Pharmacopeia (USP) Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products. 

More Information on Visual Inspection

Published by PDA/DHI: Visual Inspection and Particulate Control
A practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize and educate seasoned inspectors with the principles of microscopy and seasoned microscopists with the elements of visual inspection, this book describes ways to find visible defects and what to do with them once found. Available in hardcover or electronic format.

Exhibit

View the exhibitor flyer for a list of sponsor benefits. Contact eventos@pdabrazil.org or phone 11-5181-0732 for sponsorship opportunities for this event.

Program Planning Committee

Thank you to the committe for organizing this event!

  • Samara Mateiro, Sanofi
  • Jorge Anselmo, MSD
  • Alexandre Terada, Allergan
  • Tereza Amaral, Novartis
  • Tathiane Castro, Amgen
  • Wolfgang Löscher Filho, Libbs
  • Deolinda Izumida, West
  • Leonidas Orjuela, Audisis Vale
  • Flavia Pierin, MSD
  • Eduardo Ribolla, MSD
  • Luís Fernando Wenzel, Allergan
  • Rose Nascimento, Eurofarma
  • Bruno Lima, Biomm
Sold Out
https://store.pda.org/Meetings/Login.aspx?ID=3914

Directions