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An Introduction to Visual Inspection - Japan

Oct 31 - Nov 01, 2019
Tokyo, Japan

  • Education
  • Asia-Pacific
Closed

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 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.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

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

    Manufacturing, Quality Assurance, Validation, Engineering

    Roles

    Supervisor, Manager, Specialist, Technician, 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.

Sheraton Miyako Hotel

1 Chome-1-50 Shirokanedai
Tokyo, Japan

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  • Accommodations

    A block of rooms have been reserved for meeting participants. The rate is $30,450 JPY inclusive of taxes and breakfast. Reservations must be secured by Saturday, October 5, 2019. After this date, reservations can be made on a space and rate available basis only.

    To reserve a room at the discounted group rate please use the following link:
    https://advance.reservation.jp/miyakohotels/stay_pc/rsv/cc_pln_dtl_redirect.aspx?cp=2&lang=en-US&hi_id=1&smp_id=935&cp_id=2019APRC&is_cal=True

    Individual Cancellation

    Please be aware that obtaining and cancelling hotel reservations is the responsibility of the registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

FROM NARITA AIRPORT

By Limousine Bus
Narita Airport → (Limousine bus: Approx. 120 min) → Hotel
Limousine Bus Fares

Adult (Junior high student or older) 3,100 JPY
Child (Elementary school student or younger) 1,550 JPY

FROM HANEDA AIRPORT

By Limousine Bus
Haneda Airport → (Limousine bus: Approx. 75 min) → Hotel

Adult (Junior high student or older) 820 JPY
Child (Elementary school student or younger) 410 JPY

By Car

BY TOKYO CITY BUS

Journey time: Approx. 5 min

  • For the journey from Meguro Station to the hotel by the Tokyo City Bus, take a bus bound for Ooi-keibajo (Ooi Racetrack) <Line Shina 93> and get off at the Shirokanedai Station bus stop.
  • For the journey from Shinagawa Station to the hotel by the Tokyo City Bus, take a bus bound for Meguro Station <Line Shina 93> and get off at the Shirokanedai Station bus stop.

Other Options

BY TRAIN

Train
Shinagawa Station → (JR Yamanote Line 160 JPY/8 min) → Meguro Station → (Subway 170 JPY/2 min) → Shirokanedai Station → (Approx. 4 min walk) → Hotel

Taxi
From Shinagawa Station Approx. 7 min/Approx. 1,100 JPY
From Meguro Station Approx. 5 min/Approx. 730 JPY

FROM STATION

Hotel Shuttle Bus
The hotel also serves a free shuttle bus on these routes in some time periods of a day. Please see the below
“Hotel Shuttle Bus” description.

Journey time: Meguro Station Approx. 5 min
Journey time: Shinagawa Station Approx. 7 min

  • Meguro Station ←→ Sheraton Miyako Hotel Tokyo
  • Sheraton Miyako Hotel Tokyo → Shinagawa Station

Directions

Registration Fees

Regular Price
Registration Type Price
Member USD $899
Non-member USD $899
Gov't/Health Auth./Academic* USD $899



* 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.

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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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Tel: +49 (0) 30 43 655 08-10
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