LIFE SCIENCE INSPECTION READINESS CONFERENCE

NOVEMBER 6-7, 2017 | ALEXANDRIA, VA

COURTYARD BY MARRIOTT ALEXANDRIA PENTAGON SOUTH

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DAY TWO | TUESDAY, NOVEMBER 7

8:30 REGISTRATION & MORNING COFFEE

8:55 OPENING REMARKS

9:00 CASE STUDY: SUCCESSFULLY NAVIGATING INTERNATIONAL INSPECTION REQUIREMENTS
In an effort to evolve in conjunction with an expanding global marketplace, inspection readiness personnel are responsible for preparing for inspections for a multitude of international markets. The varying requirements and expectations of global health authorities has created a bevy of challenges for quality inspection executives to overcome; including gaining familiarity with regional regulatory expectations anticipating common inquiries from international health authorities, and simultaneously ensuring compliance throughout a variety of regions. Through the following case studies, quality inspection executives will share lessons learned and strategies utilized to ensure inspection readiness in three key international markets.

Akie Yamashita, Director, NSF HEALTH SCIENCES

 

9:50 ALIGNING FRONT & BACK OFFICE FOR INSPECTION SUCCESS
Organizational design of a front and back room is crucial to audit success, and both the front room and back room require specific considerations for quality auditors. The front room requires inspection coordinators to be attentive, and impeccably organized as it is the formal inspection area where the regulatory authorities review requested documents and conduct employee interviews. At the same time, the back room must excel at constant and effective communication, since it is the axis of the inspection process where requests are received, documents are provided, and subject matter experts await for interviews with regulatory inspectors. Exploring the necessary preparation for each room, as well as frameworks to allow front and back rooms to function in unison is key for success on the day of inspection.

9:50 MODULE 1: FRONT ROOM

  • Professional & skillful interactions with regulatory agencies
  • Effectively delegating requests from health authorities
  • Ensuring risk mitigated legal compliance in in information sharing
  • Consistent approach to sharing of information with regulators

Heather Harte-Hall, Director, Compliance, ADAPTIMMUNE

10:15 MODULE 2: BACK ROOM

  • Internal conferencing tools to receive inspector requests
  • Successfully forecasting and preparing follow up requests
  • Screening documents prior to sending them to inspectors

Shauna Franklin, Sr. Global Quality Systems Manager, ASTELLAS PHARMA


10:40 COFFEE & NETWORKING BREAK


11:10 AFTER THE INSPECTION: POST-AUDIT ACTIVITIES FOR CONTINUOUS INSPECTION READINESS

Following a regulatory inspection, quality auditors are often tasked with a multitude of post-inspection responsibilities. Quality issues are commonly discovered during routine regulatory inspections correctly identify issues in a robust and effective manner, inspection readiness professionals must identify the root cause of the deficiency, correct the complaint and demonstrate that the corrective actions applied were effective. Educational modules will provide quality audit professionals techniques to both adequately identify the root cause of an issue, as well as methods to demonstrate the effectiveness of the correction.

  • Methods to showcase CAPA effectiveness
  • Qualitative vs quantitative methods for verification checks
  • Timelines for conducting verification checks

Rob Fasciano, Director of Quality, CALIBER THERAPEUTICS


12:00 LUNCHEON FOR ALL CONFERENCE PARTICIPANTS


1:00 ENSURING STANDARD OPERATING PROCEDURES SUPPORT DATA INTEGRITY & INSPECTION READINESS

  • Validation of SOPs against documentation and GMPs
  • Monitoring site-staff procedures to ensure compliance
  • Aligning documentation & data with an eye on integrity

David Dills,Principal Regulatory Affairs, Compliance & Quality Consultant, NOVAQUAL

 

1:50 MDSAP INSPECTION/AUDIT FRAMEWORK
The Medical Device Single Audit Program (MDSAP) pilot concluded in December 2016, and numerous regulators have set deadlines to transition to the updated audit program guidelines. While the simplification of a single audit utilized by multiple agencies has clear benefits, there are many concerns that quality audit executives are tasked to address, including incorporating the multiple country specific clauses , allocating resources for updated audit preparation, and tracking varying timelines for full implementation of MDSAP. It is critical for quality auditors to have a thorough understanding of the essential components and potential challenges for MDSAP to ensure staff are equipped to clearly forecast inspection readiness requirements for the upcoming audit program.

Kimberly A. Trautman, Executive Vice President, NSF HEALTH SCIENCES

 

2:40 CLOSING REMARKS & CONFERENCE CONCLUSION