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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 (Invited), 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.

Information coming soon.

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

Information coming soon.
Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3606

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