LIFE SCIENCE INSPECTION READINESS CONFERENCE

NOVEMBER 6-7, 2017 | ALEXANDRIA, VA

COURTYARD BY MARRIOTT ALEXANDRIA PENTAGON SOUTH

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DAY ONE | MONDAY, NOVEMBER 6

8:00 REGISTRATION & MORNING COFFEE

8:50 OPENING REMARKS

9:00 PANEL: CREATING A CULTURE OF QUALITY: OPERATING IN A STATE OF CONSTANT READINESS
In the highly regulated environment surrounding the life science industry, being fully prepared for an inspection is crucial for an organization’s success. Prior to an inspection, quality audit personnel are often challenged with correcting organizational practices that could potentially cause regulatory objections. Inspection readiness executives recognize the necessity of shifting assessment preparation from a singular event prefacing an anticipated inspection, to a constant protocol that is embedded within the culture of an organization.

  • Delegating responsibilities to ensure constant readiness
  • Recognizing and correcting non-compliant conduct
  • Creating and implementing day to day readiness protocols

John Giantsidis, Senior Director – Specialty Surgical Solutions, INTEGRA LIFESCIENCES

Dennett Kouri, VP of Quality, Strategy, and Execution, EDWARDS LIFESCIENCES

 

9:50 DATA INTEGRITY MODULE: OPTIMIZING DOCUMENT GENERATION, MANAGEMENT AND AUDIT READINESS
A core area of regulatory audit inspection includes the analysis and review of GMP documentation to support and validate that the correct standard operating procedures have been implemented and utilized throughout the manufacture of health products, with data required to represent an accurate picture of the product and procedures used to create the end product. With a variety of challenges related to data integrity, including the assurance that documents have been generated accurately and correctly from the initiation, to the increasing trend of transitioning to electronic documentation and the ramifications on legacy data, attendees will gain tremendous value from the following data integrity modules.

 

9:50 MODULE 1: CREATION OF AUDIT TRAILS & PREPARATION OF DATA FOR REGULATORY INSPECTION

  • Archiving of data in a comprehensive & logical manner
    • Audit files for past 3-5 years
    • Previous inspection data
  • Alignment of SMEs with data trail knowledge to smooth audits
  • CAPA documentation and validated corrective actions

Greer Lautrup, Partner, SIDLEY AUSTIN

 

10:40 COFFEE & NETWORKING BREAK

 

11:10 OPEN DISCUSSION: OVERCOMING CHALLENGES IN TRANSITIONING TO ELECTRONIC DOCUMENTATION

  • Increasing reliance on electronic documentation & technology
  • Best practices in converting from paper to electronic documentation
  • Demonstrating accurate calibrations in electronic data
  • Archiving of data, scanning to e-file legacy paper documents
  • Backing up both electronic & physical documentation
  • Auditor sophistication and technological knowledge

Carol Beirne, Faculty Director, NORTHWESTERN UNIVERSITY

 

11:35 OPEN DISCUSSION : AVENUES TO OPTIMIZE ROOT CAUSE ANALYSIS

  • Differentiating direct cause vs root cause
  • Varying methodologies for conducting RCA
  • Implementing risk management strategies in RCA

 

12:00 LUNCHEON FOR ALL CONFERENCE PARTICIPANTS

 

1:30 PANEL: BALANCING INTERNAL AUDITS AGAINST EXTERNAL MOCK AUDIT CONSULTANTS
While preparing for audits and inspections is a priority for all corporations across the life science industry, depending on the size and level of staff, corporations may have internal auditors assisting with preparedness or may contract with external consultants to conduct audits, or use a combination of both in order to ensure readiness. Having internal audit staff has great value, with internal staff having tremendous functional knowledge of products and procedures, as well as knowledge surrounding the practices of staff. At the same time, external auditors can often approach mock audits with an unbiased eye, identifying critical deficiencies and data integrity issues that internal auditors can at times miss. Taking a balanced approach and recognizing the value of both internal and external audit partners will ensure corporations are at the highest state of readiness.

Christopher A. Fanelli, Senior Associate, HOGAN LOVELLS

Dennett Kouri, VP of Quality, Strategy, and Execution, EDWARDS LIFESCIENCES

Alex Smith, Director of Regulatory Sciences, HOGAN LOVELLS

 

2:20 BREAKOUT SESSION: OVERCOMING CHALLENGES OF VARYING REGULATORY INSPECTION METHODS
Regulatory auditors from the same organization can have differing approaches and focus points for inspections, creating an increasing challenge for inspection readiness executives to concisely identify potential problem points within a facility. Small group discussion format will allow delegates to knowledge share with industry peers to gain a breadth of knowledge on varying experiences with FDA auditors that will ultimately increase preparedness for future inspections.

Alex Smith, Director of Regulatory Sciences, HOGAN LOVELLS

 

3:10 COFFEE & NETWORKING BREAK

 

3:40 DESIGNING & CONDUCTING EFFECTIVE INSPECTION READINESS & AUDIT TRAINING
Consistent and regular training of staff on audit preparedness, from sitestaff to subject matter experts and internal auditors is essential in building a culture of compliance where staff are trained and empowered with the appropriate skills to handle any audit or inspection scenario. Effective training must meet the educational needs of inspection staff, combining didactic theory as well as practical skills training and as such must be developed with care, and regularly revisited to meet the needs of trainees. Conducting and evolving training for inspection preparedness is a core aspect of ensuring on-the-day audits and inspections run smoothly and with positive results.

  • Training internal auditors to act like FDA investigators
  • Conducting routine mock audits that identify deficiencies
  • Creation of a rubric to measure training impact

Pat McNally, Site Quality Director, MALLINCKRODT PHARMACEUTICALS

 

4:30 END OF DAY ONE CONFERENCE ACTIVITIES

 

5:00-6:00 PM CONTINUED NETWORKING COCKTAIL HOUR SPONSORED BY Q1
Q1 realizes the value in peer-to-peer networking at this conference, and we want to provide attendees with an opportunity to continue the networking after the first day of sessions. Please join us on Monday November 6th at 5 PM for  cocktail hour with appetizer, wine and beer.