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2019 PDA Practical Application of Sterile Manufacturing Workshop

Defining the Future with Novel Technology
Mar 13 - Mar 14, 2019 |
Mar 14, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Conference
  • Western Hemisphere Events
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Join us after the 2019 Annual Meeting in San Diego, CA when PDA hosts a workshop on the Practical Application of Sterile Manufacturing. This workshop will provide a venue for obtaining the latest information on the development of novel technologies for aseptic processing in the bio/pharmaceutical industry. The forum is ideal for those who are interested in the future of sterile manufacturing.

The Workshop's theme is Defining the Future with Novel Technology. The planning committee is bringing together the best in aseptic processing technology – both today's reality and tomorrow's developments. Together we will consider how novel technologies will define the future of our industry, and will improve the quality, speed, and reliability of aseptic manufacturing.

When we consider the emerging innovations in barrier technologies, implementation of robotics, ongoing adoption of rapid test methods, integrating new requirements such as PUPSIT into existing processes, embracing new tools such as virtual training, and the challenges that personalized medicine presents to conventional technologies, the clear message for the next decade is that technological innovation is going to remain a critical success factor in the production of sterile products.

Join us for this important workshop where attendees will learn about technological innovations and discuss the important regulatory and compliance elements that will facilitate the adoption of these emerging technologies in our global marketplace.

Sessions will focus on:

  • Improving sterility assurance through the use of technology
  • Innovation in education of staff to minimize product exposure risks
  • Modernization of current manufacturing facilities to adopt novel technologies
  • Validating and proving the effectiveness of new technologies
  • Ensuring risk management and compliance strategies are keeping pace with technological advancements

Don't miss out on this important learning opportunity. Make plans now to attend the 2019 PDA Sterile Application of Sterile Manufacturing Workshop.

Learning Objectives

Example learnings at the completion of this event include:

  • How robotics can eliminate human intervention and make production more reproducible
  • How gloveless isolators and compartmentalized filling units are changing how we think about commercial aseptic fill lines
  • How technology is advancing training and education in our industry to reduce human error rates, enhance comprehension and retention
  • How rapid testing is challenging our preconceptions about release testing and test method validation
  • How technology is being used to make PUPSIT a reality in existing processes; impact of PUPSIT on the reliability of sterile filtration, and addressing compliance concerns
  • How the challenges of potent compounds are being addressed with novel barrier technology innovations

Who Should Attend

Job Functions
Scientist | Executive and Mid-Level Management | Engineer | Analyst | Investigator | Auditor | Project Manager

Departments
Manufacturing Technology | Product Development | Quality | Manufacturing | Validation | Regulatory Affairs | Engineering | Automation | Information Technology | Data Science | Operational Excellence | Risk Management | Sterility Assurance

Contacts

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

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

Exhibition inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: hall@pda.org

Wednesday, March 13

3:15 p.m. - 6:00 p.m.
Registration Open

3:15 p.m. - 6:00 p.m.
Exhibit Area Open

4:15 p.m. - 6:00 p.m.
P1: Novel Technologies Associated with Sterile Manufacturing
Moderator: Shelley Preslar, General Manager, Azzur Group South East

Aseptic processing continues to be a hot topic in our industry. Consistently being able to produce a sterile product comes with a certain set of challenges and process requirements. Fortunately, the industry continues to push into the future, and novel techniques, equipment and technology are constantly evolving. In this session, we’ll hear examples where novel technology has been utilized to improve aseptic production capabilities. What challenges did they face when implementing the new technology, and what did they learn when the project was over?

4:15 p.m. - 4:30 p.m.
Welcome and Opening Remarks from the Planning Committee Co-Chairs
Rebecca Brewer, Vice President of Strategic Practices, Quality Executive Partners
Dawn Downey, PhD, Senior Consultant Engineer, Eli Lilly and Company

4:30 p.m. - 5:00 p.m.
Industry Presenter Invited

5:00 p.m. - 5:30 p.m.
Industry Presenter Invited

5:30 p.m. - 6:00 p.m.
Questions and Answers/ Discussion

6:00 p.m. - 7:00 p.m.
Networking Reception in Exhibit Area

Thursday, March 14

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.
P2: Rapid Microbiological Testing for Pharmaceutical Products
Moderator: Sabina Lancaster, Global Sterility Assurance Manager, Novartis Technical Operations

The pharmaceutical industry has been slow to embrace rapid microbiological testing. Rapid testing can enable us to get product test results faster, allowing us to make the most appropriate decisions about our batches, saving valuable time and ensuring that product can reach the patient as quickly as possible while still assuring safety. With great technical advances being made in this area, the session will focus on using rapid methods in the lab including sterility test applications where several weeks are currently required to assess Biological Indicator growth. Learn from companies that are already using rapid methods and the challenges they have faced to validate and implement such solutions.

8:30 a.m. - 9:00 a.m.
Sterility Testing Validation Using the BacT as an RMM: A Case Study
Ana P. Fonseca, Principal Scientist, Novartis

9:00 a.m. - 9:30 a.m.
Industry Presenter Invited

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

9:45 a.m. - 4:00 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.
P3: Novel Technology for Training and Operations
Moderator: Rebecca Brewer, Vice President of Strategic Practices, Quality Executive Partners

Reduction of human error non-conformance and the assurance of data integrity are present in everyone’s minds today. Other industries have successful track records in the use of technology such as Virtual Reality, Augmented Reality, and novel computer interface devices that are hands free to reduce human errors through enhanced training and error-free operations, but these technologies are just beginning to make inroads to the pharmaceutical industry. Learn from case studies focusing on the selection, development, validation and implementation of a few of these novel technologies and how they have improved training, without having to enter the cleanroom, and operations, by reducing down-time and preventing human errors.

10:45 a.m. - 11:15 a.m.
Using Virtual Reality to Transform Learning
Mirella Evans, BSc, Head, Sterility Assurance Learning Center, Novartis

11:15 a.m. - 11:45 a.m.
Implementation of Voice Recognition with EBR for Error-Reduction
Grace DiCecco, Senior Director of IT Global Factory Operations, AstraZeneca (Invited)

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

12:15 p.m. - 1:30 p.m.
Lunch on your own

1:45 p.m. - 3:15 p.m.
P4: PUPSIT
Moderator: Dawn Downey, PhD, Senior Consultant Engineer, Eli Lilly and Company

The regulatory requirement for Pre-Use Post Sterilization Integrity Testing (PUPSIT) stated in EU Annex 1 has caused companies filling sterile liquid products not only to include PUPSIT testing on new lines, but also to address legacy products where PUPSIT may not have been initially considered. The session will present discussions on current work by PDA and BPOG to consider the technical and compliance needs for PUPSIT as well as the impact on patient safety for sterile filtration systems. Case studies of implementation to address the requirement and the challenges involved will be reviewed. Learnings from companies that have already implemented PUPSIT and performed studies will include “lessons learned” in how the EU Annex 1 requirement was addressed.

1:45 p.m. - 2:15 p.m.
Areas Where PUPSIT is Not Technically Advantageous
Maik W. Jornitz, CEO, G-CON Manufacturing

2:15 p.m. - 2:45 p.m.
Industry Presenter Invited

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

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

4:00 p.m. - 5:30 p.m.
P5: Isolator Systems
Moderator: Richard Denk, Head Containment, SKAN AG

The Isolator System Session will cover the new Draft Annex 1 requirements for aseptic processing within Isolators for Air supply, decontamination and glove management as well as cleaning and decontamination of indirect product contact surfaces. Furthermore, a case study is provided for the potential patient exposure to highly-potent API (HPAPI) from potential cross-contamination through the HPAPI Dispensing to the liquid filling and lyophilization process. The intent of this Session is to raise awareness of the risk(s) to patients and the implementation of adequate risk-based controls such as containment process(es), use of adequate surrogates in cleaning validation/verification, test method-sensitivity-based cleaning validation acceptance conditions as well as Operator Protection during manufacturing.

4:00 p.m. - 4:30 p.m.
Requirements for Contamination and Cross Contamination Control
Richard Denk, Head Containment, SKAN AG

4:30 p.m. - 5:00 p.m.
Potential Patient Exposure to Highly-Potent API (HPAPI) from Potential Cross-Contamination through the HPAPI Dispensing to Liquid Filling and Lyophilization Processes
Amir Zandnia, Senior Project Engineer, Fresenius Kabi

5:00 p.m. - 5:30 p.m.
Questions and Answers/Discussion with Session Presenters and Additional Panelists

5:30 p.m.
Closing Remarks & Adjournment from the Program Planning Committee Co-Chairs

Workshop Registration | September 18-19

Member

By July 30, 2019
$1,495

After July 30, 2019
$1,695

Non-member

By July 30, 2019
$1,695

After July 30, 2019
$1,895


Young Professional Member †

Member

By July 30, 2019
$748

After July 30, 2019
$848

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


Government/Health Authority/Academic

Member*

By July 30, 2019
$700

After July 30, 2019
$700

Non-member*

By July 30, 2019
$800

After July 30, 2019
$800

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


Student

Member

By July 30, 2019
$280

After July 30, 2019
$280

Non-member*

By July 30, 2019
$310

After July 30, 2019
$310


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 cancellation notice is not received by August 16, 2019 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 in the 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 is received on or before August 16, 2019, 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.

CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be cancelled, 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 cancellation. 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: Tape recordings are prohibited at all PDA Events.

For more information on PDA's Privacy and Event Privacy Policies, please visit pda.org/privacy-policy and pda.org/event-privacy-notice.

Marriott Marquis

Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101
Tel: +1 (619)-234-1500

Rate: Single/Double: $289/per night*

*Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice.

Cut Off Date: Monday, February 11, 2019

(The PDA block of rooms are available on a first come basis and must be secured by the cut-off date to receive the PDA rate). After the cut-off date, rooms will be available at the prevailing rate based on availability.

Amenities

Immerse yourself in the charm of San Diego by staying at Marriott Marquis San Diego Marina. Situated on the waterfront with a 466-slip marina, our four-star hotel is within walking distance to the best of downtown. Ideal for both business travelers and vacationers, the hotel is steps from the San Diego Convention Center and within walking distance to City Walk, the Gaslamp Quarter, Seaport Village and Petco Park. After exploring the area, relax in our spacious accommodations, all offering either scenic city or waterfront views. Take a dip in one of our two freeform swimming pools, indulge in an onsite spa treatment, or keep your workout routine in our fitness center. Enjoy award-winning cuisine at Marina Kitchen Restaurant & Bar, or sample inventive Asian-fusion at Roy's. Boasting 83 event venues, outfitting with advanced audiovisual technology and combining for nearly 277,000 square feet of space, our hotel is also the premium choice for business functions, weddings and special events in downtown San Diego.

Read more about the amenities offered at the Marriott Marquis San Diego.

Airport

San Diego International Airport- (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel.

Ground Transportation

Taxis

Taxis are on standby at the San Diego International Airport (SAN), offering service to and from the Marriott Marquis San Diego Marina for an approximate fare of $18 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 15 minutes.

Directions

From San Diego International Airport
Turn left on Harbor Drive. Follow Harbor Drive along waterfront. Hotel will be on right (about 2 miles).

Hotel Parking

Self-parking at the Marriott Marquis San Diego Marina is $10 hourly, $35 daily. Valet parking is $50 daily.

For more information about exhibit and sponsorship opportunities, please contact David Hall at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org or Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4624

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