2021 PDA Remote Audits and Inspections Workshop
Registration Options
Individual Registration
Group Registration
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:
- Apply practical solutions and best practices when planning for and participating in remote audits and inspections.
- Assess various technologies and techniques for effective use in remote audits and inspections, including in conducting facility tours.
- Determine the value of remote audits versus on site audits while ensuring their efficiency.
- Identify issues relating to cultural differences, verbal and non-verbal communication, and time zone differences.
- Apply a risk assessment approach to the planning and scope of conducting remote audits.
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
More information coming soon.
Day 1
Monday, 13 September
09:30 – 11:15 EDT | P1: Practical Experiences |
09:30 – 09:50 EDT | Welcome and Opening Remarks from Workshop Chair 09:50 – 10:10 EDT | Virtual Internal Audits: One Company’s Perspective 10:10 – 10:30 EDT | Virtual Audits of Suppliers: What Could Possibly Go Wrong? 10:30 – 10:50 EDT | MHRA Desktop Inspections: What We've Learned 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 |
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 |
11:45 – 12:05 EDT | Risk Based Approach 12:05 – 12:25 EDT | Alternative Risk-Based Approach 12:25– 12:45 EDT | Q&A 12:45 – 13:00 EDT | Wrap-Up and Closing Remarks from Workshop Chair |
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.