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Parenteral Drug Association Connecting People, Science and Regulation ®

An Introduction to Visual Inspection - October

Oct 25 - Oct 26, 2017 |
Oct 26, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

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

Topics to be addressed include:

  • 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
  • Inspection Lifecycle development

Who Should Attend

  • Manufacturing: Managers, Supervisors
  • R&D: Managers, Supervisors
  • Engineers
  • Validation
  • Quality

Upon completion of this course, you 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

Standard

Member

On or Before September 08, 2017
$2,419

After September 08, 2017
$2,699

Nonmember

On or Before September 08, 2017
$2,915

After September 08, 2017
$3,239


Government/Health Authority/Academic

$1,619

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 25, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Manager, Education
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

John Shabushnig, PhD, Insight Pharma Consulting, LLC.

John 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).

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), currently serving on the Board of Directors (2003-2011, 2016) and previously as Chair (2008-2009) and has served on the Science Advisory Board (SAB) (as a member 2004-2016) and as Chair (2012-2014) and Vice-Chair (2010-2011, 2015). He organized and continues to lead the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute (TRI). 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 spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and the visual inspection of pharmaceutical products. He is a co-author of the recently published book Visual Inspection and Particulate Control.

Ronald Leversee, Perrigo Company

Ron has over 30 years of experience in pharmaceutical manufacturing with over 15 years of direct operations leadership experience in parenteral products with specialization in Freeze Drying, Visual Inspection and Packaging operational areas. He has experience with sterile vial, pre-filled syringe, and various liquids OTC processes and is a Certified Quality Auditor through the American Society of Quality. He has spent the past 9 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.

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 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 improvement, regulatory compliance, and the subject matter expert for visual inspection at the site and across the Pfizer Network. During this time Matt has had a number of developmental opportunities including; 2 years in the Aseptic Processing /Filling and Freeze Dry Department, and assigned to two projects 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 Instructor 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.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #417 | ACPE #0116-0000-14-064-L04-P | 1.2 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.

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