2021 PDA Remote Audits and Inspections Workshop

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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 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.

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.

More information coming soon.

Day 1

Monday, 13 September

09:30 – 11:15 EDT | P1: Practical Experiences
Moderator: Vishal Sharma, Co-Founder-Director, Vienni Training & Consulting LLP

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.

09:30 – 09:50 EDT | Welcome and Opening Remarks from Workshop Chair
Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring

09:50 – 10:10 EDT | Virtual Internal Audits: One Company’s Perspective
Ee Lynn Kok, Director, Enterprise Regulatory Compliance, Johnson & Johnson

10:10 – 10:30 EDT | Virtual Audits of Suppliers: What Could Possibly Go Wrong?
Siegfried Schmitt, PhD, Vice President Technical, Parexel

10:30 – 10:50 EDT | MHRA Desktop Inspections: What We've Learned
Ewan Norton, Lead Senior GMDP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)

10:50 – 11:15 | Q&A

11:15 – 11:30 EDT | Break

11:30 – 13:00 EDT | P2: Anticipating Perils and Pitfalls: Impact of Culture on Communication during Remote Audits
Moderator: Peter D. Smith, Principal, Smith GMP Consulting

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, VP Quality, Neuroderm - a Mitsubishi Tanabe Pharma Group Company
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

Day 2

Tuesday, 14 September

09:30 – 11:30 EDT | P3: Optimizing Support of Global Regulatory Remote Facility Inspections or Audits
Moderator: Lynne A. Ensor, PhD, Vice President, RCS Head of Global Compliance, PAREXEL International

This session will feature speakers from various global regulatory agencies to improve understanding and provide clarifications regarding regulatory expectations during remote facility inspections or audits. Recommendations will be shared for optimizing regulatory interfaces as well as preparing to host these types of inspections. Lastly, a case study will be presented highlighting a remote regulatory inspection supporting the approval for commercial manufacture of a regenerative medicine.

09:30 – 09:50 EDT | Dong Jiangping, Deputy Director-General, Center for Food and Drug Inspection, China Food and Drug Administration

09:50 – 10:00 EDT | Q&A with Dong Jiangping

10:00 – 10:20 EDT | Hemant G. Koshia, MPharm, PhD, Commissioner, Food and Drugs Control Administration (FDCA), Gujarat, INDIA

10:20– 10:40 EDT | Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA

10:40– 11:00 EDT | Scott R. Nichols, PhD, Associate Director - Global Quality Compliance, Kite Pharma

11:00 – 11:30 EDT | Q&A

11:30 – 11:45 EDT | Break

11:45 – 13:00 EDT | P4: Risk-Based Approach
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.

11:45 – 12:05 EDT | Risk Based Approach
Tiffany Baker, MBA, Consultant, ValSource Inc. and Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

12:05 – 12:25 EDT | Alternative Risk-Based Approach
Iain Moore, PhD, Global Head of Quality Insurance, Croda International

12:25– 12:45 EDT | Q&A

12:45 – 13:00 EDT | Wrap-Up and Closing Remarks from Workshop Chair
Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring

Agenda is subject to change.

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