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2019 PDA Practical Application of Sterile Manufacturing Workshop

Mar 13 - Mar 14, 2019
San Diego, CA

Defining the Future with Novel Technology

  • Conference
  • The Americas
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Overview

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.

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Agenda

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  • Day 1
  • Day 2

  • Wednesday, March 13

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

    3:15 p.m. - 7:00 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-Chair
    Rebecca Brewer, Vice President of Strategic Practices, Quality Executive Partners

    4:30 p.m. - 5:00 p.m.
    Get Ready, Set, Transform! Looking into the Future of Sterile/Aseptic Manufacturing and its Transformation
    Hal Baseman,     Chief Operating Officer, ValSource LLC
    Glenn Wright, Senior Director, Quality Operations, Exelead

    5:00 p.m. - 5:30 p.m.
    Aseptic Intervention Logging and Evaluation: A Case Study
    Frederic B. Ayers,     Research Scientist, Indianapolis Parenteral Operations, 
    Eli Lilly and Company

    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. - 5:00 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.
    Implementation of Rapid Plate Count for Environmental Monitoring: A Case Study
    Chris Knutsen, PhD,     Technical Fellow, Bristol-Myers Squibb

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

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

    9:45 a.m. - 3:30 p.m.
    Exhibit Area Open

    10:00 a.m. - 10:30 a.m.
    Refreshment Break in Exhibit Area

    10:30 a.m. - 12:00 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.

    10:30 a.m. - 11:00 a.m.
    Using Virtual Reality to Transform Learning
    Mirella Evans, BSc, Head, Sterility Assurance Learning Center, Novartis

    11:00 a.m. - 11:30 a.m.
    Design, Development and Validation Considerations for Advanced Training Technologies
    Rebecca Brewer,     Vice President of Strategic Practices, Quality Executive Partners

    11:30 a.m. - 12:00 p.m.
    Questions and Answers/Discussion

    12:00 p.m. - 1:30 p.m.
    Lunch 

    1:30 p.m. - 3:00 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.

    1:30 p.m. - 2:00 p.m.
    A Case Study in PUPSIT Implementation
    Steven Ensign, Senior Consultant Engineer, Eli Lilly and Company

    2:00 p.m. - 2:30 p.m.
    Update of the Workflows of the PUPSIT Task Force
    Maik W. Jornitz, CEO, G-CON Manufacturing

    2:30 p.m. - 3:00 p.m.
    Questions & Answers/ Discussion with Session Presenters and Additional Panelist
    Hal Baseman,     Chief Operating Officer, ValSource LLC

    3:00 p.m. - 3:30 p.m.
    Refreshment Break in Exhibit Area

    3:30 p.m. - 5:00 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.

    3:30 p.m. - 4:00 p.m.
    Requirements for Contamination and Cross Contamination Control
    Richard Denk, Head Containment, SKAN AG

    4:00 p.m. - 4:30 p.m.
    Design of a HPAPI Production Suite from Dispensing to Liquid Filing and Lyophilization Processes
    Amir Zandnia, Senior Project Engineer,Fresenius Kabi

    4:30 p.m. - 5:00 p.m.
    Questions and Answers/Discussion with Session Presenters and Additional Panelists
    Hal Baseman,     Chief Operating Officer, ValSource, LLC
    Shelley Preslar, General Manager, Azzur Group South East

    5:00 p.m.
    Closing Remarks & Adjournment from the Program Planning Committee Co-Chair
    Dawn Downey, PhD,     Senior Consultant Engineer, Eli Lilly and Company


Additional Information

  • Learning Objectives

    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

    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

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Marriott Marquis San Diego

333 West Harbor Drive
San Diego, CA

  • Accommodations

    The PDA room block is now closed. However, reservations can still be made on a space-and-rate available basis. Please contact the Marriott Marquis San Diego directly at +1 (888)-236-2427.

    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. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    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 3 days prior to the date of arrival to avoid cancellation fees.

  • 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.

How to Get Here

By Air

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

Ground Transportation

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.

By Car

The Marriott Marquis San Diego is located at 333 West Harbor Drive, San Diego, CA 92101.

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.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants $1,095




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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Feb 11, 2019, no fee will be charged. After Feb 11, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Feb 11, 2019, a full refund will be given minus a $200 fee. After Feb 11, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
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