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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Visual Inspection Forum

Oct 23 - Oct 24, 2017 |
Oct 24, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: October 23-24
Courses: October 25-26
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Visual inspection continues to be an important element of the manufacturing process and the quality assurance of injectable products. Product inspection provides necessary information for lot release, and, coupled with defect identification, contributes to a strategy of continuous process improvement. Past topics have included selection and qualification of human inspectors, validation of automated inspection systems, container integrity and inspection, particle identification and characterization, recent regulatory activity and country specific inspection requirements.

The 2017 Visual Inspection Forum will provide case studies, explore new USP chapters<790> and <1790>, and discuss new developments in the field of visual inspection, including contributions to a basic understanding of the sampling and inspection process, practical aspects of manual and automated methods, and the regulatory and compendial requirements that govern them.

The meeting will feature an exhibition where attendees can see the latest in commercial inspection hardware and discuss production needs with key suppliers of inspection systems and services.

Learning Objectives

At the completion of this event, participants will be able to:

  • Identify particulate inspection methods and equipment
  • Identify critical parameters that affect the inspection process
  • Develop state-of-the-art methodologies which reflect current industry knowledge
  • Describe compendial requirements and regulatory trends to ensure their companies are meeting current and anticipated regulatory expectations
  • Implement an effective and economical visual inspection process

Who Should Attend

Departments
Engineering | Manufacturing | Packaging | Process Development | Quality | Technical Services | Validation

Pharmaceutical/Biopharmaceutical Developers
Clinical Supplies | Parenteral Development | Process Development

Inspection Equipment Suppliers
Applications Development | Machine Design | Sales

Contact

Jason E. Brown
Senior Manager, Programs & Registration Services
Tel: (301) 656-5900 ext. 131
Email: brown@pda.org

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

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1 (240) 688-4405
Email: hall@pda.org

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Monday, October 23, 2017

7:15 a.m. - 5:15 p.m.
Registration Open

7:15 a.m. - 8:15 a.m.
Continental Breakfast

8:15 a.m. - 8:30 a.m.
Welcome and Opening Remarks from Planning Committee Co-Chair
John Shabushnig, PhD,
Principal Consultant, Insight Pharma Consulting, LLC 

8:30 am. - 10:00 a.m.
P1: Regulatory Compendial Issues
Moderator: Markus Lankers, PhD, Director, Research & Development, rap.ID Particle Systems GmbH 

Session Description: The first talk will provide regulatory perspectives on Visual Inspection issues. The second talk will summarize the recommendations on inspector training and qualification, supplemental testing and complaint investigation found in USP <1790>.  It will also provide reference to other USP chapters that discuss particulate testing.

8:30 a.m. - 9:00 a.m.
Current Thinking on Visual Inspection/Particles and Experiences in the Field
Regulatory Representative Invited

9:00 a.m. - 9:30 a.m.
USP <790> and USP <1790>: Status and Recent Experience
John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

9:30 a.m. - 10:00 a.m.
Questions & Answers/Discussion

9:45 a.m. - 6:45 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break & Poster Presentations in Exhibit Hall

10:45 a.m. - 12:15 p.m.
P2: Particle Control & Characterization
Moderator: Roy Cherris, Managing Partner, Bridge Associates International

Session Description: The first talk will address trials and tribulations of investigating, identifying, and preventing sources of visible particulate matter. Evaluations of production and control processes for ampoules and lyophilized vials will be discussed. The second presentation will discuss both manual and automated analyses that can be applied to found particulate to identify what the unknown materials are.  Each method, to include microscopy, FTIR, SEM-EDS, Raman, and light obscuration particle counting, and the results that can be expected from each method will be discussed.  Pros and cons of manual versus automated methods will be discussed, as well as what types of samples are best suited for each method.   Case studies for various methodologies will be presented as well as examples of why a certain method was chosen for a particular type of sample.  Additionally, the process of finding and submitting the most relevant reference materials for source determination and ultimately root cause analysis will also be discussed.

10:45 a.m. - 11:15 a.m.
Particles: An Approach to the Perspective of “Practically/Essentially” Free
Linda Wilding, Head of Quality Projects and Science Pharmaceuticals, Takeda Austria GmbH

11:15 a.m. - 11:45 a.m.
I Can See It, Now What Is It? A Guide for What Happens After Visual Inspection
Cara Plese, Senior Scientist, Gateway Analytical

11:45 a.m. - 12:15 p.m.

Questions & Answers/Discussion

12:15 p.m. - 1:30 p.m.
Exhibitor Roundtable Luncheon:
Connect with colleagues and exhibitors during lunch, while discussing “hot” topics in the industry.

1:30 p.m. - 3:00 p.m.
P3: Challenging or Difficult to Inspect Products
Moderator: John Ayres, MD, JD, Senior Medical Fellow, Product Safety Assesments, Eli Lilly and Company

Session Description: This session begins with a presentation that summarizes the topic of PM-DIP and the current PDA Task Force’s recommendations on these challenging products. The second presentation analyzes the results of a study of probability of detection (POD) shifts due to changes in a drug product's appearance. In addition, it compares and analyzes POD shifts relative to clear, water-like solution due to changes in solution color, and separately, solution clarity, for several different types of typical defect materials found in parenteral manufacturing facilities.

1:30 p.m. - 2:00 p.m.
Introducing the New PDA Technical Report on Particulate Matter in Difficult to Inspect Parenteral Products
Roy Cherris, Managing Partner, Bridge Associates International

2:00 p.m. - 2:30 p.m.
A Case-Study Examination of POD Shifts Generated by Difficult-to-Inspect Products
Daniel A. Calderon, Visuals Supervisor, Micro Measurement Laboratories, Inc.

2:30 p.m. - 3:00 p.m.
Questions & Answers/Discussion

3:00 p.m. - 3:45 p.m. 
Refreshment Break & Poster Presentations in Exhibit Hall

3:45 p.m. - 5:15 p.m.
P4: Managing Product Challenges
Moderator: Richard (Rick) Watson, Director, Sterile & Validation COE, Merck & Company/Merck Sharp & Dohme Corporation

Session Description:The first presentation will provide a summary of challenges related to visual appearance testing of freeze-dried products, particularly on how to judge the criticality of cake appearance. Furthermore, a harmonized nomenclature and description for variations in cake appearance from the ideal expectation of “uniform and elegant” will be provided. Finally, a science- and risk-based approach for establishing acceptance criteria for cake appearance will be discussed. The second presentation explores the collaborative work of two companies for the development and implementation of advanced software algorithms used on an automatic syringe inspection machine.  Successful reduction of false fails while maintaining selective detection of foreign artifacts in viscous and other types of fluids will be addressed.

3:45 p.m. - 4:15 p.m.
Lyophilized Drug Product Cake Appearance: What is Acceptable?
Sajal Patel, PhD, Senior Scientist, MedImmune

4:15 p.m. - 4:45 p.m.
Advanced Particle Detection Software Algorithms to Reduce False Rejection in Viscous and other Types of Fluids
Al Goodwin, Principal Engineer, Machine Vision SME, Amgen, Inc.

4:45 p.m. - 5:15 p.m.
Questions & Answers/Discussion

5:15 p.m. - 6:45 p.m.
Networking Reception in Exhibit Hall

Tuesday, October 24, 2017

7:30 a.m. - 5:30 p.m.
Registration Open 

7:30 a.m. - 8:30 a.m. 
Continental Breakfast

8:30 a.m. - 10:00 a.m.
P5: Manual Inspection
Moderator: John Shabushnig, PhD, Principle Consultant, Insight Pharma Consulting, LLC

Session Description: This session begins with a case study that details the effort to implement a comprehensive program to align the visual inspection of a difficult to inspect product with the USP <790> requirements. The first presentation will describe the 100% inspection process, the non-destructive AQL testing, the destructive reconstituted sample AQL testing, and the AQL result trending process that was implemented. It will also discuss the incorporation of risk-based assessment of visible particulate into the assignment of AQLs, project planning and regulatory filing. The second presentation will discuss the limitations of traditional AQL based acceptance sampling. An alternative strategy to link clinically relevant risk assessment with historical trending with the objective of detecting and responding to significant shifts in low defect levels will be discussed.

8:30 a.m. - 9:00 a.m.
Case Study: Implementation of USP <790> for a Difficult to Inspect Product
Richard (Rick) Watson, Director, Engineering, Merck & Company/Merck Sharp & Dohme

9:00 a.m. - 9:30 a.m.
Beyond AQL Sampling: An Innovative Approach to Setting Limits for and Ensuring Conformance to Visual Defect Specifications
Elizabeth Zybczynski, Director, Risk Management, Baxter Healthcare

9:30 a.m. - 10:00 a.m.
Questions & Answers/Discussion

9:45 a.m. - 4:00 p.m.
Exhibit Hall Open

10:00 a.m. - 10:45 a.m.
Refreshment Break & Poster Presentations in Exhibit Hall

10:45 a.m. - 12:15 p.m.
P6: Biopharmaceutical Inspection
Moderator: Deborah Shnek, PhD, President, Drug Product Development, LLC

Session Description: The first presentation will discuss A semi-quantitative method for assessing inherent visible particles will the setting of quality control limit(s).  It will also include bridging studies for a second generation method. Historical inspection consistency for the first and second generation methods will also be addressed. The second presentation will address how the BioPhorum Operations Group (BPOG) has developed a 'Proof of Concept' (PoC) Standardized Methodology risk assessment tool for objectively assigning a risk value to particulates in parenteral biologics drug products considering patient impact. On Behalf of BPOG, a summary of this methodology and its usage will be presented.

10:45 a.m. - 11:15 a.m.
Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
Stephen Krause, PhD, Director of Quality Assurance Technical Support, AstraZeneca Biologics

11:15 a.m. - 11:45 a.m.
Update on BioPhorum Operations Group (BPOG) Activities and the Particulate Risk Reduction Initiative
Shilan Motamedvaziri, PhD, Principal Engineer, Manufacturing Science & Technology, Bristol-Myers Squibb

11:45 a.m. - 12:15 p.m.
Questions & Answers/Discussion

12:15 p.m. - 1:45 p.m.
Lunch on your own. Exhibit Hall Closed -
A listing of local restaurants are available at the PDA Registration Desk.

1:45 p.m. - 3:15 p.m.
P7: Primary Packaging Materials
Moderator: Thomas Arista, Field Investigator, Microbiological Inspections, ORA,  FDA

Session Description: This session will begin with a presentation on a significant initiative to bring together executives, including CEOs and vice presidents, from biologic and pharmaceutical manufacturers with glass container and elastomeric closure suppliers to prepare industry for the complex products and manufacturing processes of the future. They aspire to achieve this through collective and collaborative continuous improvement projects to take today's world-class injectable medicine manufacturing to the next level. The second talk will present real cases to illustrate the steps needed to keep an automated inspection machine working at optimum performance. The methodologies described in this discussion are applicable for any automated inspection machine.

1:45 p.m. - 2:15 p.m.
Enabling Reduction in Visible Particulates through Strong Industry Collaboration and Partnerships
Jennifer Johns, Director, Packaging & Device Services, Pfizer, Inc.

2:15 p.m. - 2:45 p.m.
The Reality of Commodity Variations and their Impact on Automated Visual Inspection Machines: A Case-Study Discussion of Root Cause Methodology, Understanding Limits of Automated Visual inspection and Determining Effective Paths to Effect Meaningful Change
Robert Harding, Process Engineer, Sanofi Pasteur

2:45 p.m. - 3:15 p.m.
Questions & Answers/Discussion

3:15 p.m. - 4:00 p.m.
Refreshment Break, Poster Presentations & Passport Raffle in Exhibit Hall

4:00 p.m. - 5:30 p.m.
P8: Automated Inspection
Moderator: Markus Lankers, PhD, Managing Director, rap.ID GmbH

Session Description:  The first talk provides an overview of a compliant approach to the implementation of a multi-staged automation inspection process. It will closely review the process design and qualification requirements to ensure that a multi-staged inspection process is implemented in a complaint manor. The second presentation will give an overall view of automated visual inspection qualification methodologies commonly used in the industry, compare these methodologies and give guidance to the audience based on their unique situations, which method may work the best.

4:00 p.m. - 4:30 p.m.
Compliant Approach to Implementation of Multi-Staged Automated Inspection
Robert Crews, Associate Director, External Quality Assurance, Merck & Company/Merck Sharp & Dohme

4:30 p.m. - 5:00 p.m.
Automated Visual Inspection (AVI) Machine Qualification Strategies
Mitsutaka Shirasaki, Senior Engineer, Genentech, Inc.

5:00 p.m. - 5:30 p.m.
Questions & Answers/Discussion

5:30 p.m.
Closing Remarks from Planning Committee Co-Chair

Markus Lankers, PhD, Managing Director, rap.ID GmbH

Forum Registration | October 23-24, 2017

Member

Before August 14, 2017
$1,895

August 14, 2017 – September 8, 2017
$2,095

After September 8, 2017
$2,295

Non-member

Before August 14, 2017
$2,174

August 14, 2017 – September 8, 2017
$2,374

After September 8, 2017
$2,574


Government/Health Authority/Academic

Member

Before August 14, 2017
$700

August 14, 2017 – September 8, 2017
$700

After September 8, 2017
$700

Non-member*

Before August 14, 2017
$800

August 14, 2017 – September 8, 2017
$800

After September 8, 2017
$800


Student

Member

Before August 14, 2017
$280

August 14, 2017 – September 8, 2017
$280

After September 8, 2017
$280

Non-member*

Before August 14, 2017
$310

August 14, 2017 – September 8, 2017
$310

After September 8, 2017
$310


All prices in US dollars.

* For this member type, online registration is not available must be faxed in.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund and photo release policies for this Forum.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Forum and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by August 24, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If your written request in received on or before August 24, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive Forum materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA Forums.

Bethesda North Marriott HotelBethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852
Phone: +1 (301) 822-9200

Rate: Single: $239.00, plus applicable state and local taxes.

Cut Off Date: Monday, September 25, 2017 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

Hotel Accommodations

To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference the PDA Visual Inspection Forum to receive the PDA group rate. Check in time is 4:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 20 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.

Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.

Hotel Parking
$15 Self Parking.

Sponsorship and Exhibit Opportunities are Available!

High impact, cost-effective sponsorship and exhibition packages are available for the 2017 PDA Visual Inspection Forum. Gain on-site exposure and connect with industry experts from manufacturing, engineering, packaging, process development, quality, technical services, and validation. Exhibit at or sponsor this Forum to align your company with leading-industry minds and world-class content.

Comprehensive sponsorship packages will provide your company the opportunity to strengthen brand image, increase visibility, and reinforce its commitment to the visual inspection arena. Sponsorships are available for lanyards, tote bags, notepads, pens, refreshment breaks, lunch, networking reception, and more.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales
Tel: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | Fax: +1 (301) 986-0296 | Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3611

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