Friday April 28, 2017 from 8:00 AM to 5:00 PM PDT
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International Technological University

2711 N 1st St

San Jose, CA 95134



Azadeh Adibi
Course Coordinator 
ASQ Silicon Valley - Section 0613 



Suzanne Geiss

Susie Geiss
Education Committee Chair
ASQ Silicon Valley - Section 0613 



B108 - Complaint Handling 

  • To discuss the mechanics of conducting a recall with a focus on the practical side of this activity and the level of detail the FDA requirements will be.  This will cover both U.S and International requirements.
  • (21 CFR Sections 806 and 810)
  • How to decide if a recall is necessary
  • What the FDA expectations will be?
  • Effectively following up on the recall
  • Closing the recall activity
  • Script development for discussions with customers affected by the recall
  • Practice in interpreting regulations
  • Develop a usable resume that adapts the participants' current skills to the Biomedical industry
  • Interact with industry professionals on a personal basis

Instructor Bill Kurani

Bill Kurani   

Instructor Bio

  • Mr. Bill Kurani has years of experience in product design, development, clinical trials, verification, validation, process validation & launch. Implemented Software Life Cycle based on IEC 62304, 60601, 61010, and GAMP and provided validation services.


Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.


Course Details

Prerequisites: None
Hardware: N/A   |  Software: N/A                              
Required Materials: 

- Proof of online Payment 

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach, class discussions and examples
Class Time: 8 hours
Class Size:  25 max. participants
Facilities: Room with PC projector, whiteboard, etc.