PDA 417 Introduction to Visual Inspection
Registration Options
Individual Registration
Group Registration
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.
Upon completion of this training course, the attendee will be able to:
- Identify applicable international regulatory and compendial requirements for visual inspection
- Apply the critical parameters which must be controlled for reproducible inspection results
- Use appropriate statistical tools to assess and compare inspection methods
- Develop consistent validation strategies for visual inspection processes and equipment
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Early Bird Pricing
Register before 19 April 2024
Early Bird Member Price
$2,249GovernmentMember Only
$1,749
Health AuthorityMember Only
$1,749
AcademicMember Only
$1,749
Non-Member
$2,699
Standard Pricing
Register after 19 April 2024
Standard Member Price
$2,499GovernmentMember Only
$1,749
Health AuthorityMember Only
$1,749
AcademicMember Only
$1,749
Non-Member
$2,999
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].
Featured Trainers
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Ronald Leversee
Padagis US LLC
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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.
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Matthew Ostrowski
Pfizer, Inc.
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Matthew Ostrowski
Pfizer, Inc.
Matt was hired by Pharmacia in 1998 as a Packaging Line Coordinator in the Dry Products Department working mainly on the Blisters and Tablet lines. In 1999, Matt became an Instructor for Pharmaceutical Manufacturing where he was responsible for training, SOP documentation, and revisions for the entire Packaging Department. In 2000, Matt was promoted to the Production Coordinator in Sterile Inspection, and in 2002, he took on the role as the Inspection Supervisor which he held until 2013.
In January of 2013, Matt’s role within Pfizer changed from Supervisor to Process Technologist for the Injectable Inspection Department. In his current role, Matt’s responsibilities include process improvements, regulatory compliance, and the subject matter expert for visual inspection at the site. During this time, Matt has had a number of developmental opportunities including 2 years in the Aseptic Processing/Filling and Freeze Dry Department, and two project assignments at two separate Pfizer sites. The first was to assist with a new plant startup and product launch, and the second was at another site to develop a visual inspection process and inspection line improvement project. Along with his normal job duties, Matt is a member and Trainer for the Parenteral Drug Association teaching courses in Visual Vial Inspection and Aseptic Processing. In 2009, Matt graduated from Spring Arbor University with a Bachelor’s Degree in Business.
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John G Shabushnig, PhD
Principal Consultant, Insight Pharma Consulting, LLC
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John G Shabushnig, PhD
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 is leading 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.
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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
Accommodations
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD
20814