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PDA 417 Introduction to Visual Inspection

Oct 17 - Oct 18, 2023
Bethesda, MD

  • Education
  • The Americas
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Program Highlights

Overview

This training course covers the fundamentals of visual inspection and their application to injectable products. It will be a combination of lecture/discussion and hands-on exercises used to develop and practice practical inspection skills. The skills developed through this training course may be applied to both manual human inspection and automated machine inspection.

During this training course, you will learn about patient risks associated with particles in injections; global compendial and regulatory requirements and expectations; inspection techniques for visible particles and container closure defects; critical quality parameters for manual, semi-automated and automated inspection methods; light measurement and control; key elements of a visual inspection program; and inspection lifecycle development.

For more options and/or related training courses, please visit the page(s) below.

PDA Visual Inspection Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast will not be provided, but lunch will be provided.

Trainers

Ronald Leversee
Ronald Leversee
Padagis US LLC
Bio
Ronald Leversee
Padagis US LLC

Ron has over 37 years of experience in pharmaceutical manufacturing with over 15 years of direct operations leadership and experience in parenteral products with specialization in Freeze Drying, Sterile Filling, Visual Inspection, and Packaging operational areas. He has experience with ophthalmic drug products, sterile vial, sterile cartridges, and pre-filled syringes. Ron is a Certified Quality Auditor through the American Society of Quality. He has spent the past 15 years presenting and instructing various Visual Inspection topics and courses through the PDA Visual Inspection Forum and Visual Inspection Training Course in both Berlin and the Training and Research Institute (TRI) in Bethesda, MD. Ron has an Associate in Applied Science Degree in Electronics Technology from Kalamazoo Valley Community College, Bachelor of Science Degree in Manufacturing Engineering and Masters of Science in Engineering Management both from Western Michigan University. He currently resides in Kalamazoo, MI.
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC
Bio
John G. Shabushnig
Insight Pharma Consulting, LLC

John is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.

John holds a BS in Chemistry from Carroll College and a PhD in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and leads the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection.

He is a co-author of the recently published book Visual Inspection and Particulate Control.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify applicable international regulatory and compendial requirements for visual inspection
    2. Apply the critical parameters which must be controlled for reproducible inspection results
    3. Use appropriate statistical tools to assess and compare inspection methods
    4. Develop consistent validation strategies for visual inspection processes and equipment
  • Who Should Attend

    This training course is intended for professionals who are involved with visual inspection of parenterals in sterile drug manufacturing.

    Departments
    Quality Control, Engineering, Manufacturing, Quality Assurance Operations, Research and Development, Validation

    Roles
    Specialist, Operator/Technician, Supervisor, Manager, Engineer

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By September 2, 2023
Member $2,249
Non-member $2,699
Gov't/Health Auth./Academic $1,749

Regular Registration
Registration Type Price After September 2, 2023
Member $2,499
Non-member $2,999
Gov't/Health Auth./Academic $1,749

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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