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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Annex 1 Workshop

Oct 02 - Oct 03, 2017 |
Oct 03, 2017 |
Omni Shoreham Hotel | Washington, DC
  • Workshop
  • Western Hemisphere Events
Exhibition: Oct. 2-3
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The 2017 PDA Annex 1 Workshop is designed to present the newly released draft revision to Annex 1, Manufacture of Sterile Medicinal Products of the European Union Guidelines to Good Manufacturing Practice of Medicinal Products for Human and Veterinary Use. The revision has been developed by a joint working group between PIC/S and EMA with input from global health authorities.

The Workshop will bring together regulators, contributors, industry experts and the actual people who will have to implement  on a daily basis the new requirements to review the content of the Annex, focusing on changes and the most important topics for you as representatives of industry, manufacturers of sterile product and those regulated by European health authorities. This will be a unique, immediate and time sensitive opportunity to hear explanation of the revision from experts, understand background, interpretation and expectations and provide direct input to health authority representatives on content and usage of the Annex.

The 2017 PDA Annex 1 Workshop will focus primarily on the topics of most concern in our industry, as such much of the two-day sessions will involve discussion over the most challenging aspects of modern aseptic processing facing globally-oriented companies.

Day 1 of the Workshop will start with explanation by Andrew Hopkins, committee chair of the PIC/S EMA working group for the revision of the Annex 1, and the need and underlying principles, that caused  the revision of the document’s content. Plenary sessions will then present areas of discussion gathered from input from PDA meetings and events – including:

  • Expectations for and effective use of risk-based decision making and planning;
  • Design, classification and operation of clean room facilities;
  • Personnel training, qualification, supervision, monitoring and performance; and
  • Better use and interpretation of environmental monitoring. 

Day 2 will address the more debated topics; those where there may not yet be consensus in the industry or where further explanation is warranted. These will be presented in an innovative point/counter-point format, with experts presenting advantages and disadvantages, and risks and benefits of four very key topics:

  • Post-sterilization pre-use integrity testing of sterilizing filters (PUPSIT);
  • Vapor phase hydrogen peroxide (VHP) sterilization/decontamination of indirect product contact surfaces;
  • Container closure integrity (CCI) of glass and stopper sealed vials and prefilled syringes; and
  • Reaction to microbiological excursions in the critical Grade A environment.

Days 1 and 2 will include small group break out discussions on these and other topics to determine comments and collect feedback  for the health authorities on these and other recent topics. Following both days, there will be interactive panel discussions with speakers and participants to further address topics, breakout session reports and provide input to health authorities on the revisions.

Contact

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

Crystal Roberson
Coordinator, Programs
Tel: (301) 656-5900 ext. 100
Email: roberson@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

Monday, October 2, 2017

7:00 a.m. – 5:30 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

8:15 a.m. – 8:30 a.m.
Welcome and Opening Remarks from Program Planning Committee Co-Chair
Hal Baseman, Chief Operating Officer, ValSource, LLC

8:30 a.m.– 10:00 a.m.
P1: Overview and Revision Process of Annex 1
Moderator: Richard M. Johnson,
President and CEO, PDA

Session Description: This workshop will kick off with a session presenting the needs, background, procedure, and content of the revised Annex 1 GMP guidance for sterile pharmaceutical product manufacturing from the perspective of the leadership of the health authority committee responsible for the preparation of the revision, as well as from the perspective of the industry chair of the task force that authored the recently published PDA Points to Consider for Aseptic Processing: Parts 1 and 2.

8:30 a.m. – 9:00 a.m.
Annex 1 Overview: Updates and Revisions
Andrew Hopkins, Expert GMDP Inspector, Medicines and Healthcare Products Regulatory Agency

9:00 a.m. – 9:30 a.m.
Industry Perspectives: Challenges and Opportunities
Hal Baseman, Chief Operating Officer, ValSource, LLC

9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion

9:45 a.m. – 6:30 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: Risk-Based Thinking and Cleanroom Design
Moderator: Guenther Gapp, PhD, Consultant, Gapp Quality GmbH

Session Description: Regulators and industry experts agree that modern risk- and science-based approaches should be used to develop and implement control strategies and acceptance criteria designed to ensure the establishment and maintenance of suitable manufacturing conditions that affect the quality and safety of products. This session will provide concrete examples on how risk management tools and approaches can be used in practice to not only to identify risk, but also to allow the improvement of processes, facilities and control strategies.

10:45 a.m. – 11:15 a.m.
How Risk Tolerance Impacts our Thinking about Aseptic Processes
James Vesper, PhD, Director, Learning Solutions, ValSource, LLC

11:15 a.m. – 11:45 a.m.
Cleanroom Design
Phil DeSantis, MS, Principal, DeSantis Consulting Associates

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. – 1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:15 p.m.
P3: Personnel and Environmental Monitoring
Moderator: William H. Miele, PhD,
Director, Global Aseptic Support, Pfizer Inc.

Session Description: Personnel and environmental monitoring are key assessment and control processes to minimize risk in aseptic processing. Some regulatory requirements are stated quantitatively while others may describe expectations with little information addressing “how to.” This leaves a manufacturing site to incorporate established regulation into the development and description of their own process, possibly resulting in varying approaches and programs in our industry. This session will explore current industry approaches in the context of an evolving environment dealing with the science, technology and conventions of today.

1:30 p.m. – 2:00 p.m.
Personnel
Guenther Gapp, PhD, Consultant, Gapp Quality GmbH

2:00 p.m. – 2:30 p.m.
Environmental Monitoring
Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Company

2:30 p.m. – 3:15 p.m.
Questions and Answers/Discussion

3:15 p.m. – 4:00 p.m.
Refreshment Break in Exhibit Area

4:00 p.m. – 5:30 p.m.
P4: Breakout Session 1
Moderator:
Hal Baseman, Chief Operating Officer, ValSource, LLC

Session Description: Workshop attendees will be assembled in smaller, facilitated groups. Groups will be identified by a colored dot on each attendee's badge. This session offers the opportunity to discuss a series of topics and questions related to the revised Annex 1 content.  Comments on specific items and topics will be noted for later discussion and critique. Emphasis will be given to topics and requirements which present manufacturing and inspection challenges and ways to meet those challenges. During the last 30 minutes of the session, each group will have an opportunity to give feedback on a particular topic.

5:30 p.m. – 6:30 p.m.
Networking Reception 

Tuesday, October 3, 2017

7:00 a.m. – 4:30 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

8:30 a.m. – 10:00 a.m.
P5: Industry and Regulatory Challenge Topic Debate Part 1
Moderator: Hal Baseman,
Chief Operating Officer, ValSource, LLC

Session Description: Day two sessions are designed to encourage and stimulate the exchange of views on topics where industry consensus may not be yet fully formed. The sessions will be organized into point and counter- point interactive discussions with experts presenting alternate views, advantages and potential disadvantages of selected topics. The sessions will begin with a report on two important, recently published PDA surveys addressing aseptic processing in general and PUPSIT (pre-use, post-sterilization integrity test). Following the survey report, the first point/counter-point discussion will involve the relative benefits and risks of the use of PUPSIT in sterile product manufacturing.

8:30 a.m. – 9:00 a.m.
PDA Survey Analysis (Aseptic and PUPSIT Surveys)
Richard M. Johnson, President and CEO, PDA

9:00 a.m. – 10:00 a.m.
Pre-use, Post-sterilization Integrity Testing (PUPSIT): Benefits versus Risk |
Andrew Hopkins, Expert GMDP Inspector, Medicines and Healthcare Products Regulatory Agency
Maik W. Jornitz, MS, CEO, G-CON Manufacturing, Inc.

9:45 a.m. – 4:15 p.m.
Exhibit Area Open

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

10:45 p.m. – 12:45 p.m.
P6: VHP, Container Closure Integrity Testing and Excursions in Grade-A Environment
Moderator: Steven J. Lynn, MS, CMQ/OE,
Global Head, Group Compliance and Audit, Novartis Services, Inc.

Session Description: The revised Annex 1 is promising to contain changes to how companies deal with multiple facets of aseptic manufacturing. Join us in this session where we will discuss a few of these key topics, including new technologies and usability in container closure integrity testing (CCIT), vaporized hydrogen peroxide (VHP) decontamination and excursions in a Grade-A environment.

10:45 a.m. – 11:15 a.m.
Design of a Meaningful Control Strategy for Container Closure Integrity (CCI) | Should CCI be used as release criteria?
Derek Duncan, PhD, Director, Product Line Europe, LIGHTHOUSE Instruments

11:15 a.m. – 11:45 a.m.
Decision Tree on the use of Vaporized Hydrogen Peroxide (VHP) | Is VHP an effective means to decontaminate or sterilize indirect product contact parts?
Geert Vandenbossche, PhD, Global Head Biologics Technical Development and Manufacturing Quality, Drug, Novartis

11:45 a.m. – 12:15 p.m.
Excursions in Grade-A Environment | Should microbiological excursions in the Grade-A Environment result in batch rejection?
Marcia C. Baroni, Director, QC Microbiology & EM/Sterility Assurance, Eli Lilly and Company

12:15 p.m. – 12:45 p.m.
Questions and Answers/Discussion

12:45 p.m. – 2:00 p.m.
Networking Luncheon

2:00 p.m. – 3:30 p.m.
P7: Breakout Session 2
Moderator:
Hal Baseman, Chief Operating Officer, ValSource, LLC

Session Description: Attendees will break out into groups to debate some of the key issues related to the previous sessions. This session will include several questions for discussion, and members of the Program Planning Committee will facilitate the discussion to try to develop consensus. During the last 30 minutes of the session, each group will have an opportunity to give feedback on a particular discussion topic.

 

3:30 p.m. – 4:15 p.m.
Refreshment Break in Exhibit Area

4:15 p.m. – 5:00 p.m.
P8: Panel Discussion on the Draft Revision of Annex 1 and the Points of Agreement/Controversy
Moderator: Richard M. Johnson,
President and CEO, PDA

Session Description: The final session features a panel of industry and regulatory experts that will participate in an interactive discussion on key topics pertaining to the Annex 1 draft revision.

Hal Baseman, Chief Operating Officer, ValSource, LLC
Andrew Hopkins, Expert GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
William H. Miele, PhD, Director, Global Aseptic Support, Pfizer Inc.

5:00 p.m.
Closing Remarks 
Richard M. Johnson, President and CEO, PDA


Workshop Registration | Oct. 2-3, 2017

Member

Before Jul. 25, 2017
$1,895

Jul. 25, 2017 – Aug. 21, 2017
$2,095

After Aug. 21, 2017
$2,295

Non-member

Before Jul. 25, 2017
$2,174

Jul. 25, 2017 – Aug. 21, 2017
$2,374

After Aug. 21, 2017
$2,574


Government/Health Authority/Academic

Member

Before Jul. 25, 2017
$700

Jul. 25, 2017 – Aug. 21, 2017
$700

After Aug. 21, 2017
$700

Non-member*

Before Jul. 25, 2017
$800

Jul. 25, 2017 – Aug. 21, 2017
$800

After Aug. 21, 2017
$800


Student

Member

Before Jul. 25, 2017
$280

Jul. 25, 2017 – Aug. 21, 2017
$280

After Aug. 21, 2017
$280

Non-member*

Before Jul. 25, 2017
$310

Jul. 25, 2017 – Aug. 21, 2017
$310

After Aug. 21, 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 Workshop.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Workshop 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 3, 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 3, 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 Workshop 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 Conferences.

Omni Shoreham Hotel
2500 Calvert Street NW
Washington, DC 20008
Phone: +1 (202) 234-0700

Rate: Single: $259.00, plus applicable taxes (14.5%).

Cut Off Date: Monday, September 4, 2017 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.)

Hotel Accommodations

To make reservations at the Omni Shoreham Hotel, please call the Hotel at +1 (202) 234-0700 and reference the 2017 PDA Annex 1 Workshop, and the 2017 PDA Container Closure Workshop to receive the PDA group rate. Check in time is 3:00 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 by 12 p.m. three days prior to the date of arrival otherwise specified on your reservation information.

Amenities

Since 1930, the luxurious Omni Shoreham Hotel in Washington, D.C. has played host to presidents, world leaders and inaugural balls, making it a true Washington landmark. The 834 luxury guest rooms are located steps away from the National Zoo. For a full list of hotel amenities - click here.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 8 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 34 miles away.

Ground Transportation
Taxi fares from Reagan National are $20-$25 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is $50-$65 and from BWI is about $75-$100.

Metro
Woodley Park Metro Station is 0.2 miles away from the hotel and is approximately $2.35-$3.25 one way to Reagan National.

Train
Union Station is 4 miles away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Driving
Visit this page for detailed driving directions to the Omni Shoreham Hotel.

Hotel Parking
$49 / Valet parking only - per car, per day

The 2017 PDA Annex 1 Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This workshop will bring together industry experts from Microbiology, Validation, Engineering, Quality, Regulatory, Sterility Assurance, Process Development and Operations.

Good foot traffic is one thing; good leads are another. At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

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

Closed
https://www.pda.org/global-event-calendar/events-misc-info/onsite-registration

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