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2017 PDA Quality Risk Management for Manufacturing Systems Workshop

Effective and Practical Application of QRM to the Design, Qualification and Operation of Pharmaceutical Manufacturing Systems
Jun 19 - Jun 20, 2017 |
Jun 20, 2017 |
Hyatt Centric Chicago Magnificent Mile | Chicago, IL
  • Workshop
  • Western Hemisphere Events
Exhibition: June 19-20
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Top Reasons to Attend the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop

  1. To hear from the most driving force in the industry, Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority, and one of the foremost global experts on QRM.
  2. To be one of the very first to learn about PDA's brand new, practical and effective approach to using QRM for key decision making directly from the authors of the upcoming PDA Technical Report No. 54-5, PDA Quality Risk Management for the Design, Qualification and Operation of Manufacturing System.
  3. To find out how to transition to QRM approaches that will help you streamline decision making, optimize resources utilization, increase efficiencies and meet the expectations of global health authorities.
  4. To understand the value and true role of QRM from both regulatory and industry perspectives.
  5. To discover different risk-based approaches (including system-driven and process-driven) to characterizing the system design and how QRM can be practically implemented for the manufacturing quality system lifecycle.
  6. Where else can you begin your morning discussing MSOP/aging facilities and the use of new technologies?
  7. To engage in a small-group discussion facilitated by an industry expert and perform a risk assessment of a given process, putting your newly acquired skills to the test.
  8. To hear the opinions of the PIC/S Expert Circle on advanced QRM training initiatives for GMP inspectors/investigators.
  9. To ask your burning questions of regulatory and industry experts.
  10. To learn how to build a more efficient and effective pharmaceutical quality system through integration of QRM.
  11. Who can pass up a great opportunity to network with other professionals who share your challenges and interests?

We greatly encourage anyone who is or plans to be involved with the design, qualification, validation, operation or remediation of pharmaceutical or biopharmaceutical manufacturing systems to attend the one-of-a-kind, interactive 2017 PDA Quality Risk Management for Manufacturing Systems Workshop in Chicago on June 19-20, 2017.

The efficient manufacturing of high quality pharmaceutical and biopharmaceutical products is the objective of our industry. To achieve this objective, it is essential that we understand the risk to product quality and use this information as a basis for process control decisions. Quality risk management methods and criteria should not merely be a “check the box” exercise, but rather a well thought out, essential component of this decision-making process. This continues to be a prime expectation and requirement of global heath authorizes and regulators.

To help our industry ensure product quality and process efficiency, PDA developed a pragmatic, effective, workable approach to the use of QRM for key decision making in the lifecycle of manufacturing systems. This approach will be published in the upcoming PDA Technical Report No. 54-5, PDA Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems, and attendees will have the opportunity to apply the principles outlined in TR 54-5 with the guidance of the primary authors and the participation of guest regulators, who are industry experts in QRM and its application.

Take advantage of this unique opportunity to meet, listen to and interact with colleagues, notable regulators and industry leaders on the need for and use of evolving manufacturing system risk-based thinking best practices and expectations. Through informative presentations, educational material, break-out sessions and general discussion, this Workshop will instruct attendees in the use of these QRM approaches for the characterization of critical aspects of system design, the qualification of those systems and the integration of QRM principles into the pharmaceutical quality system. In addition, the Workshop will encourage dialogue between attendees, regulators and industry speakers regarding best practices and expectations.

Contact

Molly O'Neill Moir, CMP
Vice President, Programs & Meetings
Tel: (301) 656-5900 ext. 132
Email: moir@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, June 19

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

7:00 a.m. – 8:15 a.m.
Continental Breakfast

8:00 a.m. – 8:15 a.m.
Welcome and Opening Remarks
Ghada Haddad, MBA
, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck Sharp & Dohme and Co-Chair, 2017 PDA Quality Risk Management for Manufacturing Systems Workshop Program Planning Committee

8:15 a.m.– 9:45 a.m.
P1: Opening Plenary: The Value and Evolving Role of Quality Risk Management of the Manufacturing System Lifecycle
Moderator: Ghada Haddad, MBA, Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: The pharmaceutical industry has an integral role in protecting patients by supplying quality products. However, they can also put lives at risk if they don’t maintain quality of their products by evaluating the robustness of their manufacturing processes to understand and manage potential risk to product quality and thus patient safety. ICH Q8, 9 and 10 were created to ensure that the quality of products is built-into the processes and monitored within a quality management system.

Quality risk management (QRM) enables the systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle. The importance and value of QRM is highly dependent on its use and the commitment a company puts towards integration of QRM principles in their quality systems.

QRM with good manufacturing practice and science can be a powerful tool for scientific-based decision making to ensuring quality. Unfortunately practice shows that the real role of QRM is not always understood and it has become something that is only done, because it is required by the regulations.

Kevin O’Donnell will give the regulatory perspective on the value and role of QRM while Elizabeth Zybczynski will discuss the value and role of QRM from an industry perspective, focusing on risk-based lifecycle management.

8:15 a.m. – 8:45 a.m.
Value and Role of Quality Risk Management: Regulatory Perspective
Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

8:45 a.m. – 9:15 a.m.
Value and Role of Quality Risk Management: Industry Perspective
Elizabeth Zybczynski, Director, Quality, Baxter International Inc.

9:15 a.m. – 9:45 a.m.
Questions and Answers/Discussion

9:30 a.m. – 6:30 p.m. 
Exhibit Area Open

9:45 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area

10:30 a.m. – 12:30 p.m.
P2: Risk Assessment and Risk-Based Approaches to Characterizing the System Design
Moderator: Lori Richter,
Consultant, ValSource, LLC

Session Description: This session will discuss principles and tools presented in PDA TR 54-5 that can be used to help identify critical aspects of the manufacturing system and plan for design and subsequent lifecycle activities. Two risk-based approaches for characterizing the system design will be presented. The first is a more traditional system impact approach, identifying and evaluating critical system components and items against a prescribed set of criteria. The second is a process driven approach, which builds on evaluation of process risk to select and rank system elements. The session will also include a discussion on modern methods for system and process risk assessment.

10:30 a.m. – 11:10 a.m.
System-Driven Approach
Liza M. Lamb, Validation Engineer III, Wright Medical Technology

11:10 a.m. – 11:55 a.m.
Process-Driven Approach
Kelly Waldron, MBA,
Regulatory Science Researcher, Dublin Institute of Technology

11:55 a.m. – 12:30 p.m.
Questions and Answers/Discussion

12:30 p.m. – 1:45 p.m.
Networking Luncheon

1:45 p.m. – 3:15 p.m.
Breakout Session
Moderator: Hal Baseman, Chief Operating Officer, ValSource, LLC

This interactive session will use the principles and tools presented in the previous session to identify and plan the use of critical aspects of the manufacturing system. Each breakout group will perform a risk assessment of a given process. The groups will use one of the two risk-based methods presented or discuss alternate methods to assess, determine, evaluate and rank risks, critical aspects and control strategies for manufacturing systems needed to fulfill design requirements. Groups will prepare and present feedback to the larger group on approach effectiveness, results, remaining challenges and suggestions for meeting those challenges. The results of the session will be compared and critiqued, including any differing results. The results will then be used as a basis for user requirements needed for the second set of breakout groups on day two.

Facilitators
Liza M. Lamb, Validation Engineer III, Wright Medical Technology
Lori Richter, Consultant, ValSource, LLC
Christopher J. Smalley, PhD, Pharmaceutical Consultant
William Stelzenmuller, Principal Quality Engineer, Janssen, Pharmaceutical Companies of Johnson & Johnson
Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology
Steve Wisniewski, Principal Compliance Consultant, CAI Consulting


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

4:00 p.m. – 5:30 p.m.
P3: Group Reports and Panel Discussion
Moderator: Hal Baseman,
Chief Operating Officer, ValSource, LLC

Session Description: Each breakout group will present feedback from their respective breakout session to attendees, focusing on the experience of using the risk-based approach, how the approach worked, challenges uncovered, ideas for improvement and the use of risk-based thinking in the characterization of system design. Attendees will have an opportunity to ask questions and critique results.

4:00 p.m. – 5:00 p.m.
Group Reports

5:00 p.m. – 5:30 p.m.
Panel Discussion
Jason F. Chancey, Consumer Safety Officer, CDER, FDA
Liza M. Lamb, Validation Engineer III, Wright Medical Technology
Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
Carrie Ann Plucinski, Consumer Safety Officer, CDER, FDA
Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology
Elizabeth Zybczynski, Director, Quality, Baxter International Inc.

5:30 p.m. - 6:30 p.m.
Networking Reception in Exhibit Area

Tuesday, June 20

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

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

7:15 a.m. – 8:15 a.m.
Breakfast Session: Enhancing Product Quality through New Manufacturing Technology Implementation
Moderator: Richard Johnson,
President & CEO, PDA

Session Description: The differences we can see between older and newer manufacturing technologies are ever increasing. In this session, we plan to discuss implementing and leveraging such technologies as a means to mitigate manufacturing process and quality risk management. Data supporting the notion that the robustness of these new technologies will lead to quality improvements is increasing daily. However, this also leads us to pose the question: Why does it take so long to get a new technology implemented when it is truly a process improvement?

7:15 a.m. – 7:45 a.m.
New Manufacturing Technology Implementation
Maik W. Jornitz,
CEO, G-CON Manufacturing Inc.

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion


8:30 a.m. – 10:00 a.m.
P4: Practical Implementation of Quality Risk Management for Manufacturing System Lifecycle
Moderator: Christopher J. Smalley, PhD,
Pharmaceutical Consultant

Session Description: When implementing quality risk management (QRM) for the manufacturing system lifecycle, it is important to understand the drivers for QRM. Product quality and patient safety are those key drivers, and because they are, the perspective of regulatory authorities must be understood. Jason F. Chancey will be challenging us to examine new and innovative technologies and how they can be examined through the lens of QRM on improving manufacturing reliability and control. This in turn can be quantified in improvement to product quality, patient safety and reduction in market interruptions. Kevin O’Donnell, PhD will describe the efforts by the PIC/s Expert Circle to upskill regulatory inspectors and investigators in QRM and encourage the industry to do similar advanced upskilling work for itself. Further, ideas are solicited from the industry on how to achieve higher levels of competency in QRM.

8:30 a.m. – 9:00 a.m.
The Use of Risk-Based Thinking to Promote the Use of Modern Technology
Jason F. Chancey, Consumer Safety Officer, CDER, FDA 

9:00 a.m. – 9:30 a.m.
The PIC/S Expert Circle on Quality Risk Management: Inspector Training Initiatives on Advanced QRM
Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

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. – 12:45 p.m.
P5: Quality Systems: Quality Risk Management Approaches for Designing a More Effective Pharmaceutical Quality System
Moderator: William Stelzenmuller, Principal Quality Engineer, Janssen, Pharmaceutical Companies of Johnson & Johnson

Session Description: This session will discuss how to build on the previously introduced PDA TR 54-5 principles to develop practical approaches for qualification, validation and quality systems. Quality risk management (QRM) is regarded as a proactive approach toward assuring quality of products and the safety of patients. QRM with its processes should be clearly defined in the quality manual and should be an integrated part of quality management in the operation of pharmaceutical manufacturing systems. QRM integration into the pharmaceutical quality system (PQS) will ensure an effective and efficient PQS with more informed decisions and an appropriate allocation of resources. In this presentation, we will discuss the use of QRM in the System Qualification, Corrective Action/Preventive Action program, Change Management programs, investigations and other aspects of Quality Systems.

10:45 a.m. – 11:15 a.m.
Use of Risk-Based Approaches for Planning and Performance of System Commissioning, Qualification and Validation
of Critical Systems

Steve Wisniewski, Principal Compliance Consultant, CAI Consulting

11:15 a.m. – 11:45 a.m.
Risk-Based Approach to Manufacturing System Design and Operation: Linking to Product Quality and Process Requirements
Christopher J. Smalley, PhD, Pharmaceutical Consultant

11:45 a.m. – 12:15 p.m.
Building a More Efficient and Effective Quality System
Lori Richter, Consultant, ValSource, LLC

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.
Breakout Session
Moderator: Ghada Haddad, MBA, Director, Global Quality
Risk Management Center of Excellence, Merck & Co./Merck Sharp & Dohme

Breakout groups will reconvene with facilitators to use information on system critical aspects and user requirements developed during the Breakout Session 1 assessments, to develop lifecycle-focused quality system plans and approaches for Commissioning Qualification and Validation, Change Control, Deviation Management, Corrective Action/Preventive Action and Investigations. Each group will discuss the practical value of the assessment and present its findings, results, remaining challenges and suggestions for meeting those challenges to all attendees.

Facilitators
Liza M. Lamb, Validation Engineer III, Wright Medical Technology
Lori Richter, Consultant, ValSource, LLC
Christopher J. Smalley, PhD, Pharmaceutical Consultant
William Stelzenmuller, Principal Quality Engineer, Janssen, Pharmaceutical Companies of Johnson & Johnson
Kelly Waldron, MBA, Regulatory Science Researcher, Dublin Institute of Technology
Steve Wisniewski, Principal Compliance Consultant, CAI Consulting

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

4:15 p.m. – 5:45 p.m.
P6: Closing Plenary: Report Out and Panel Discussion
Moderator: Ghada Haddad, MBA,
Director, Global Quality Risk Management Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: Each group will present its results to attendees. Attendees will have opportunity to ask questions, critique results, determine where challenges remain and suggest how to best meet such challenges with future efforts.

4:15 p.m. – 5:15 p.m.
Group Reports

5:15 p.m. – 5:45 p.m.
Panel Discussion
Jason F. Chancey, Consumer Safety Officer, CDER, FDA 
Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
Carrie Ann Plucinski, Consumer Safety Officer, CDER, FDA
Lori Richter, Consultant, ValSource, LLC
Christopher J. Smalley, PhD, Pharmaceutical Consultant
Steve Wisniewski, Principal Compliance Consultant, CAI Consulting

5:45 p.m.
Closing Remarks
Hal Baseman, Chief Operating Officer, ValSource, LLC, and Co-Chair, 2017 PDA Quality Risk Management for Manufacturing Systems Workshop Program Planning Committee


2017 PDA Quality Risk Management for Manufacturing Systems Workshop Registration | June 19-20, 2017

Member

By May 5, 2017
$1,895

May 6 - May 31, 2017
$2,095

After May 31, 2017
$2,295

Non-member

By May 5, 2017
$2,174

May 6 - May 31, 2017
$2,374

After May 31, 2017
$2,574


Government/Health Authority/Academic

Member

By May 5, 2017
$700

May 6 - May 31, 2017
$700

After May 31, 2017
$700

Non-member*

By May 5, 2017
$800

May 6 - May 31, 2017
$800

After May 31, 2017
$800


Student

Member

By May 5, 2017
$280

May 6 - May 31, 2017
$280

After May 31, 2017
$280

Non-member*

By May 5, 2017
$310

May 6 - May 31, 2017
$310

After May 31, 2017
$310


All prices in US dollars.

* For this member type, online registration is not available and 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 assist you with. Contact us at registration@pda.org for assistance.

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 April 20, 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 onsite 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). Refunds for Full Workshop/Events: If your written request in received on or before April 20, 2017, 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 Workshop 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. Recordings are prohibited at all PDA Conferences.

Hyatt Centric Chicago Magnificent Mile
633 North Saint Clair Street
Chicago, Illinois 60611
Phone: +1 (312) 787-1234
Rate: Single: $259.00, plus applicable taxes and fees.

Hotel Accommodations

The PDA reservation weblink is now closed. At this point it will be on a case-by-case basis if the hotel can honor the group rate. To make reservations at the Hyatt Centric Chicago Magnificient Mile Hotel, please call the central hotel reservation line at +1 888-591-1234 and reference the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop.. 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 4 p.m. on the day before arrival.

Amenities

The Hyatt Centric Chicago Magnificient Mile Hotel is located in the heart of the windy city with a coveted address righ on Michigan Avenue. Explore all the city has to offer - from noted attractions like Navy Pier to high-end shopping along the Mag Mile. All 419 guest rooms and suites provide free wifi and the hotel offers a 24-hour fitness center, indoor pool, and an award winning Level Two restaurant.

Parking:

Hyatt Centric Chicago Magnificent Mile offers a variety of hourly, overnight, and event parking rates:

  • 0–3 hours: $36
  • 3–8 hours: $43
  • 8–24 hours or overnight: $65
  • Restaurant: $14
  • Event/banquet: $25

Transportation Centers:

  • Chicago Union Station: 2 miles
  • Ogilvie Transportation Center: 2 miles
  • Chicago Illinois Bus Station (Greyhound): 3 miles
  • Chicago Midway International Airport: 13 miles
  • Chicago O’Hare International Airport: 17 miles

Public Transit Centers:

  • Red Line L train (Chicago stop) at Chicago Avenue and State Street » Access to Lincoln Park, the Gold Coast, Chinatown, the Loop, Edgewater, Rogers Park, Lakeview, Loyola University Chicago, DePaul University, the Art Institute of Chicago, Wrigley Field, Guaranteed Rate Field
  • Pink, Green, Brown, Orange and Purple Line L trains (State & Lake stop) at State Street and Lake Street » Access to Pilsen, Old Town, River North, Ravenswood, Lincoln Square, Evanston, Oak Park, Chicago Midway International Airport, the Art Institute of Chicago, the Museum of Contemporary Art, Northwestern University
  • #2 and #157 bus routes at Ontario Street and St. Clair Street, or Ontario Street and Fairbanks Court » Access to Hyde Park, the Museum of Science and Industry, the Field Museum, Streeterville.

Exhibition and sponsorship opportunities at the 2017 PDA Quality Risk Management for Manufacturing Systems Workshop enable your company to connect with professionals and decision makers from the biopharmaceutical science and manufacturing industry. Meet attendees during breaks and the Networking Reception and share how your company is aligned with and can help them address new developments and innovations in the field. Take advantage of this opportunity to introduce new products and services to this relevant and interested audience.

This Workshop is an essential meeting for anyone involved or planning to be involved with existing and new pharmaceutical manufacturing systems. Create the best sponsorship opportunity for your company to place your brand in front of influential industry professionals.

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

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