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2018 PDA Visual Inspection Interest Group Workshop

Apr 25 - Apr 25, 2018 |
Apr 25, 2018 |
PDA Research and Training Institute | Bethesda, MD
  • Interest Group
  • Western Hemisphere Events
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A one-day meeting on visual inspection will be held in Bethesda, MD on April 25, 2018. This will be in addition to the usual sessions held as part of the PDA Annual Meeting and PDA/FDA Joint Regulatory Conference. This format offers the opportunity for extended discussion on hot topics in the field of visual inspection. Our current plan is to identify a limited number of topics for discussion to allow a thorough review. We will provide an overview of each topic and the issues which are of interest and concern. We will then discuss and develop possible solutions to these challenging issues. We welcome your suggestions on topics of interest to you in advance of this meeting.

Learning Objectives

At the completion of this workshop, attendees will be able to:

  • Identify unique testing requirements for difficult to inspect products found in USP <790> such as suspensions, freeze dried powders, colored solutions, biopharmaceuticals with inherent particles and those products in non-transparent containers
  • Develop practical implementation strategies for automated inspection methods
  • Understand the current proposal to revise EC Annex 1 and the requirements for visual inspection and container integrity testing found there

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

Workshop Inquiries
Jason Brown

Assistant Director, Programs
(301) 656-5900 ext. 131
Email: brown@pda.org

Registration Inquiries
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

Wednesday, April 25

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

7:30 a.m. – 12:15 p.m.
Registration Open

8:30 a.m. – 10:00 a.m.
P1: Proposed Revisions to Annex 1
Moderator: John G. Shabushnig, PhD,
Principal Consultant, Insight Pharma Consulting, LLC. and Visual Inspection Interest Group Leader.

Session Description: This session will look at the proposed revisions and additions to the Finishing of Sterile Products section in the recently released Annex 1 draft. This document, which governs sterile medicinal product quality in Europe, contains significant changes that may affect the way you inspect and test your products. Much has been added to this version. We will discuss:

  • What's changed / What's new
  • General visual inspection requirements
  • Manual inspection
  • Automated Methods
  • Trending Topics
  • Container integrity testing

9:45 a.m. – 5:15 p.m. 
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area

10:45 a.m. – 12:15 p.m.
P2: Difficult to Inspect Products and USP <790>
Moderator: Rick Watson,
Director, Sterile & Validation COE, Merck Co., Inc.

Session Description: This session will be a focused discussion on implementation of visible particulate process controls to meet the USP <790> and <1790> guidance, with an emphasis on the challenges posed by DIP (Difficult to Inspect Product). Topics covered in this session include:

  • USP <790> and <1790> guidance
  • Considerations of particle criticality
  • Approaches for non-destructive and Destructive AQL testing
  • Application in customer complaints
  • Regulatory approach to manage changes
  • Upcoming guidance in PDA Tech Report for Difficult to Inspect Products

12:15 p.m. – 1:30 p.m.
Lunch

1:30 p.m. – 3:00 p.m.
P3: The Future of Visual Inspection
Moderator: Rob Miller,
Senior Manager, Technical Services, Pfizer, Inc.

Session Description: This session will review technologies that have affected the visual inspection process and new technologies that may have an impact in the future. The validation of these technologies along with how regulations may impact their adoption will also be explored. Topics that will be discussed include:

  • Established and emerging tech
  • Particle/leak detection
  • Visual Inspection’s role in the control and monitoring of components and processes
  • Regulation and policy requirements

3:00 p.m. – 3:45 p.m.
Refreshment Break in Exhibit Area

3:45 p.m. – 5:15 p.m.
P4: Panel Discussion

Session Description: This session will provide the opportunity to discuss topics of specific interest to those attending the workshop that were not addressed in the earlier sessions. This will be a good opportunity to:

  • Discuss current challenges
  • Benchmark with peers
  • Discuss current regulatory and compliance environment and experience
  • Identify useful references and resources

Panelists

John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC. and Visual Inspection Interest Group Leader
Rob Miller, Senior Manager, Technical Services, Pfizer, Inc.
Rick Watson, Director, Sterile & Validation COE, Merck and Co., Inc.

Interest Group Registration | April 25, 2018

Member

By February 13, 2018
$650

After February 13, 2018
$850

Non-member

By February 13, 2018
$850

After February 13, 2018
$1,050


Young Professional Member

Member

By February 13, 2018
$325

After February 13, 2018
$425

† You must be a member to take advantage of this rate.


Government/Health Authority

Member*

$300

Non-member*

$300

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


Academic

Member

$300

Non-member*

$300

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


Student

Member

$280

Non-member*

$310

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

All prices in US dollars.

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

You must be a member to take advantage of this rate.

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 workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. 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 February 23, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. 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). Refunds for Full Conference, Workshops and Events: If your written request in received on or before February 23, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to 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. Tape recordings are prohibited at all PDA events.

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 U.S.A

From Ronald Reagan National Airport (DCA)

Take George Washington Memorial Parkway to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Metro option: Please refer to the "Public Transportation" section for details.


From Washington Dulles International Airport (IAD)

Take VA-267 E/Dulles Access Toll Road to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From Baltimore Washington International (BWI) Thurgood Marshall Airport and Points North

Take I-95 South to I-495 West (toward College Park/Silver Spring).
From I-495 West, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From the South

Take I-95 North to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.


Parking

Parking is available in the parking garage below Bethesda Towers for $12 a day. PDA does not validate parking. There are also public lots within walking distance of the facility.

Public Transportation

PDA is located on the red line at the Bethesda Metro station. Once on the street level, proceed two blocks east on East West Highway to 4350 Bethesda Towers. PDA TRI is located on the first floor.

PDA is accessible from all three airports in the area either by Metrorail, Metrobus, or both. Please see the Metro map below for details.

Metro System Map

The following hotels are conveniently located near PDA:

Hilton Garden Inn

7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
+1 (301) 654-8111

Special Hotel Rate: $192 (plus applicable taxes)

Please use the code N0033113 when making your reservation to receive the rate listed above (rates are subject to availability).


Hyatt Regency Bethesda

One Bethesda Metro Center | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 657-1234 / +1 (800) 233-1234 (US Only)

Special Hotel Rate: $189 (plus applicable taxes) | January-February, July-August, November-December

Special Hotel Rate: $225 (plus applicable taxes) | March-June, September-October

Please use the code 78056 when making your reservation to receive the rates listed above (rates are subject to availability).


Residence Inn Marriott Bethesda Downtown

7335 Wisconsin Avenue | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 718-0200

No special rates available.


DoubleTree by Hilton Hotel Bethesda

8120 Wisconsin Avenue | Bethesda, MD 20814 | 0.8 miles from PDA
+1 (301) 652-2000

No special rates available.


Hilton Rockville Hotel & Executive Meeting Center

1750 Rockville Pike | Rockville, MD 20852 | 7.0 miles from PDA
+1 (301) 468-1100

Special Hotel Rate: $169 (plus applicable taxes)

Please use the code N2703011 when making your reservation via phone. Rates are subject to availability.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Visual Inspection Interest Group Workshop offers unique sponsorship packages designed to strengthen brand image, increase visibility, and help you connect with a targeted group of industry leaders. This workshop will bring together visual inspection experts from the global biopharmaceutical industry to share information and ideas.

This is an exclusive sponsorship for a maximum of three companies, where the sponsors will be recognized on the IG Workshop website and event signage, and they will have the opportunity to meet face to face with attendees via an intimate tabletop exhibition.

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=4118

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