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2021 PDA Remote Audits and Inspections Workshop

Apr 08, 2021
10:00 AM
-
5:00 PM
| Eastern Standard Time
Online
  • Webinar
  • Virtual
  • Online

Overview

As a result of travel restrictions and other precautions taken in response to the COVID-19 pandemic, some health authorities dramatically increased their use of remote tools to inspect pharmaceutical and biopharmaceutical manufacturers in 2020. Likewise, manufacturers turned to remote tools to conduct supplier and internal audits. Each was forced to either delay audits and inspections or to shift from on-site to remote audits/inspections, whether paper-based “desktop” assessments or virtual assessments using online communication platforms.

The workshop is based on the team’s collaborative knowledge-challenges-best practice sharing and a PDA Survey,  and will support you, now and in the new normal, in applying remote audits and inspections by offering sessions on various technologies and techniques for effective use in remote audits and inspections, the value of remote audits, issues related to cultural differences, communication and risk-based approaches for planning and conduct of remote audits.

Agenda

  • Thursday, 08 April

    10:00 – 11:30 | P1: Overview of Hosting and Conducting Remote Audits and Inspections
    Moderator: Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring

    Due to lock down travel restrictions, social distancing, working from home, and other measures taken caused by the COVID-19 pandemic, health authorities and industry have been forced to move to remote audits and inspections. This rapid paradigm shift for auditors, auditees, and inspectors brings many challenges. This session will provide an overview of the new way conducting/hosting remote audits and inspections as well as elaborate on the challenges and benefits of conducting remotely. We will also explore the application of QRM for planning and conducting remote audits during the pandemic. The presenters will share practical examples how to use existing risk assessments or establish them to determine frequency and scope of audits.

    10:00 – 10:30 | Welcome and Overview from Chair
    Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring

    10:30 – 11:15 | Risk-Based Approach
    Industry Representative Invited

    11:15 – 11:30 | Q&A

    11:30 – 11:45 | Break

    11:45 – 13:15 | P2: Practical Experiences
    Moderator: Robert L. Dana, Founder and President, Elkhorn Associates Inc.

    Virtual audits are becoming an important part of a company’s Quality Assurance program due to several factors, not the least of which are the challenges brought about by the Coronavirus pandemic. But are virtual audits the same as face-to-face audits or do they pose unique challenges and opportunities? In this session, two experienced auditors will discuss their experiences in the performance of virtual audits of remote internal operations and suppliers. A regulator has also been invited to present their perspective and experiences. Ample time will be provided for questions from the workshop attendees.

    11:45 – 12:05 | Virtual Audits of Suppliers: What Could Possibly Go Wrong?
    Siegfried Schmitt, PhD, Vice President Technical, Parexel

    12:05 – 12:25 | Virtual Internal Audits: One Company’s Perspective
    Ee Lynn Kok, Enterprise Regulatory Compliance Independent Audit Johnson & Johnson

    12:25 – 12:45 | Regulatory Representative Invited

    12:45 – 13:15 | Q&A

    13:15 – 13:45 | Break

    13:45 – 15:00 | P3: Anticipating Perils and Pitfalls: Impact of Culture on Communication during Remote Audits

    In this session, presenters will conduct a live audit, showcasing how different cultures can impact the results of remote audits. We will ask the audience questions from watching the live audit, elaborating on the cultural impact on communication, as well as finding out what went right and what went wrong. Finally, we will provide participants with guidance on neutralizing the impact of culture on communication.

    Karin Baer, Global Head of Quality Assurance, Boehringer Ingelheim
    Ivy Louis, M.Pharm MBA(HRM), Founder-Director, VIENNI TRAINING & CONSULTING LLP
    Vishal Sharma, Co-Founder, VIENNI TRAINING & CONSULTING LLP
    Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring

    15:00 – 15:15 | Break

    15:15 – 17:00 | P4: Use of Technology

    15:15 – 15:35 | Technology
    Raghu Ram Pannala, PhD, Head CQC, PV & RA, Sciegen Pharmaceuticals Inc

    15:35 – 15:55 | Data Security
    Raghava Mukkamala, Director, Centre for Business Data Analytics

    15:55 – 16:15 | Industry Representative Invited

    16:15 – 16:45 | Q&A

    16:45 – 17:00 | Wrap-Up and Closing Remarks from Workshop Chair
    Eva M. Urban, MSc,
    Director QRM and Internal Audits, CSL Behring

Learning Objectives

At the completion of this event, attendees will be able to:

  1. Apply practical solutions and best practices when planning for and participating in remote audits and inspections. 
  2. Assess various technologies and techniques for effective use in remote audits and inspections, including in conducting facility tours.
  3. Determine the value of remote audits versus on site audits while ensuring their efficiency.
  4. Identify issues relating to cultural differences, verbal and non-verbal communication, and time zone differences.
  5. Apply a risk assessment approach to the planning and scope of conducting remote audits.

Registration Fees

Register Now
Through 7 March 08-24 March After 25 March
$548 $767 $986

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