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2021 PDA Remote Audits and Inspections Workshop

Apr 08, 2021
Online,

  • Workshop
  • Virtual
  • Webinar
  • Online

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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
    Tiffany Baker, MBA, Consultant, ValSource Inc. and Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    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 will also present his perspective and experiences. Ample time will be provided for questions from the workshop attendees.

    11:45 – 12:05 | Virtual Internal Audits: One Company’s Perspective
    Ee Lynn Kok, Enterprise Regulatory Compliance Independent Audit Johnson & Johnson

    12:05 – 12:25 | Virtual Audits of Suppliers: What Could Possibly Go Wrong?
    Siegfried Schmitt, PhD, Vice President Technical, Parexel

    12:25 – 12:45 | MHRA Desktop Inspections: What We've Learned
    Ewan Norton, Lead Senior GMDP InspectorMedicines and Healthcare products Regulatory Agency (MHRA)

    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
    Moderator: Ruth Miller, JD, Director of Regulatory Affairs, PDA

    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, Consultant
    Ivy Louis, M.Pharm MBA(HRM), Founder-Director, Vienni Training & Consulting LLP
    Vishal Sharma, Co-Founder-Director, 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: Technology, Opportunities, Options, and Onboarding
    Moderator: Alexandre Drapier, Global Quality GMP Compliance Support, GlaxoSmithKline

    Leveraging technology in remote audits is a key activity for a successful outcome. Remote audits are a big paradigm shift in the pharmaceutical quality department mindset. This session explores and explains the various technology options available, as well as their usage, obstacles, and advantages during the pandemic. We will discuss a few ways for verifying and assuring data integrity during a remote audit. With the use of a case study, we will dive deeper into technology tool kits. We will also have a presentation surrounding the concern of data security with available options and futuristic approaches.

    15:15 – 15:35 | Expanding Technology Usage: Broadway and Blind Spots
    Raghu Ram Pannala, PhD, Head CQC, PV & RA, Sciegen Pharmaceuticals Inc

    15:35 – 15:55 | Data Exchange and Data Security: Futuristic Options
    Raghava Mukkamala, PhD, Director, Centre for Business Data Analytics and Associate Professor, Copenhagen Business School

    15:55 – 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

Highlighted Speakers

Karin Baer
Karin Baer
Neuroderm
Tiffany Baker
Tiffany Baker
Concordia ValSource LLC
Ghada N. Haddad
Ghada N. Haddad
Merck & Co., Inc.
Ee Lynn  Kok
Ee Lynn Kok
Johnson & Johnson
Ivy Louis
Ivy Louis
Vienni Training & Consulting LLP
Raghava  Mukkamala
Raghava Mukkamala
Centre for Business Data Analytics and Copenhagen Business School
Ewan Norton
Ewan Norton
Medicines and Healthcare products Regulatory Agency (MHRA)
Siegfried Schmitt
Siegfried Schmitt
Parexel

Additional Information

  • Learning Objectives

    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.
  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Registration Fees

Early Registration
Registration Type Price by 7 March 2021
Member/Non-member $548
Regular Registration
Registration Type 08-24 March After 25 March
Member/Non-member $767 $986

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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