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2019 Visual Inspection Week

An Introduction to Visual Inspection: A hands-on course

May 22 - May 23, 2019
Berlin, Germany

Welcome to the 2019 Visual Inspection Week! The training course covers the fundamentals of visual inspection methods and their application to injectable products.

  • Education
  • Europe
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Program Highlights
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Overview

This training course covers the fundamentals of visual inspection methods and their application to injectable products. The detection and identification of visible particles is a key part of the course content, though container and closure defects are discussed as well. Students combine classroom review of current regulatory requirements and inspection methods with hands-on laboratory exercises to develop and practice practical inspection skills. The skills developed through this combination of classroom and laboratory exercises may be applied to manual human inspection, semi-automated and automated machine;inspection methods. This is also an excellent opportunity to discuss your specific inspection questions and; challenges with expert instructors.

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Agenda

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  • Day 1
  • Day 2

  • Wednesday, 22 May 2019

    9:00
    Welcome and Introduction

    • Why We Inspect
    • Patient Safety
    • Regulatory Requirements
    • Compendial Requirements
    10:30
    Coffee Break

    11:00
    Inspection Methods and Technologies

    • Critical Parameters (lighting, time, contrast and motion)
    • Manual Visual Inspection (MVI)
    • Semi-Automated Visual Inspection (SAVI)
    • Automated Visual Inspection (AVI)
    12:30
    Lunch Break

    13:30
    Particle Identification

    14:30
    Laboratory Exercise: Manual Visual Inspection

    • Light Measurement
    • Assessment effect of changing critical Variables
      • Time (10 sec vs. 20 sec)
      • Lighting (2,500 lux vs. 1,250 lux)
      • Motion/Agitation (with vs. without)
    15:30
    Coffee Break

    16:00
    Continue Laboratory Exercise

    17:30
    Wrap-up Discussion / Q&A

    18:00

    End of Day 1

  • Thursday, 23 May 2019

    9:00
    Inspection Data Review

    • From previous day’s laboratory exercise

    10:00
    Defect Classification Strategies

    • Risk classification definitions
    • Critical, Major and Minor defects
    10:30
    Coffee Break

    11:00
    Acceptance Sampling

    • Sampling Plan Variables
      • Sample SizeTime
      • AQL and UQL
    • Common Standards
      • ANSI/ASQ Z1.4
      • ISO 2859

    12:00
    Inspector Selection and Qualification

    • Vision Screening
    • Initial Training
    • Initial Qualification
    • Requalification
    12:30
    Lunch Break

    13:30
    Inspection Strategies

    • Reinspection
    • 2-Stage Inspection
    • Focused inspection
    • Empty Vial Inspection

    14:00
    Inspection Validation

    • Inspection performance Assessment
      • Knapp Method
    • Acceptance Criteria
    14:30
    Coffee Break

    15:00
    Mythbusting

    • Common misperceptions in visual inspection

    15:30
    Wrap-up Discussion / Q&A

    16:30
    End of Course

Trainers

Markus Lankers
Markus Lankers
MIBIC GmbH & Co KG
Bio
Markus Lankers
MIBIC GmbH & Co KG

Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.

Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.

He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the USA.  
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, 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), having served on the Board of Directors (2003-2011, 2016) and 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 the subjects of 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.

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this course, the attendee will be familiar with:
    • Understand current global regulatory and compendial requirements for visual inspection
    • Understand patient risk associated with visible particles in injections
    • Implement a technically sound and compliant inspection process
    • Assess inspection performance
  • Who Should Attend

    Who Should Attend

    This course is designed specifically for:

    • Injectable Drug Product Manufacturing Professionals and Management
    • Quality Professionals and Management
    • Validation and Manufacturing Engineers
    • Technical Support Staff
    • Product Development Scientists
    • Inspection Equipment Manufacturers
  • Accreditation

    Accreditation

    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 # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    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 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 (PDH) 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 PDH credits.

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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.

Courtyard by Marriott Berlin City Center

Axel-Springer-Strasse 55
Berlin, Germany

Courtyard by Marriott Berlin City Center
  • Accommodations

    Hotel Website

    The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.

    We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.

    PDA Europe has reserved a limited number of rooms until the 08th April 2019.

    Book Your Room for the PDA Group Rate
    Single Room € 135 per night*
    Double Room € 150 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • usage of Wireless LAN
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
7.1 mi (11.42 km), 22 min by car
Estimated taxi fare: 28 EUR (one way)
Bus service, fee: 2.7 EUR (one way)
Subway service, fee: 2.7 EUR (one way)
Take the bus X9 and get off at the Zoological Garden. Change to the subway U2 towards Pankow and get off at Spittelmarkt. Cross Seydelstrasse and turn right. The hotel will be on the right.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
11.7 mi (18.9 km), 23 min by car
Estimated taxi fare: 40 EUR (one way)
Bus service, fee: 3.3 EUR (one way)
Subway service, fee: 3.3 EUR (one way)
Take the bus SX1 to Südkreuz. Then change to bus 248 to S+U Bahnhof Alexanderplatz and get off at Lindenstrasse/Oranienstrasse. Turn right into Axel-Springer-Strasse, direction Axel-Springer building. The hotel is located at the very end of the street on the left hand side.

By Car

The Marriott Berlin City Center is located at Axel Springer Strasse 55.

Other Options

Bus station: Spittelmarkt, 0.1 miles.

Subway station: Spittelmarkt, 0.1 miles.

Train station: Hauptbahnhof, 3.1 miles.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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