All times mentioned are CET.
Sprecher
Dr Rainer Gnibl, District Government of Upper Bavaria, Germany
Katja Kotter, Vetter Pharma-Fertigung, Germany
Jean-Denis Mallet, PhD, Pharmaplan, France
Markus Roemer, Comes Compliance Services, Germany
Edel Ryan, Mylan, Ireland
Dr Anke von Harpe, QProgress, Germany
Katja Kotter, Vetter Pharma-Fertigung, Germany
Jean-Denis Mallet, PhD, Pharmaplan, France
Markus Roemer, Comes Compliance Services, Germany
Edel Ryan, Mylan, Ireland
Dr Anke von Harpe, QProgress, Germany
Zielsetzung
Get a detailed overview of the possibilities and limits of a Distant Assessment/ Remote Audit. Both perspectives will be considered, that of the auditor/ inspector and that of the auditee.
Hintergrund
One important part of a supplier qualification process is the performance of an on-site audit. Currently, because of the situation with the worldwide pandemic situation, site visits present a potential risk to all persons involved or might simply not be possible because of travel restrictions.
If an on-site audit is not possible, a risk-based supplier qualification process can be supported by a Distant Assessment. Such an assessment may be conducted through various communication channels such as video calls or other appropriate tools available.
If an on-site audit is not possible, a risk-based supplier qualification process can be supported by a Distant Assessment. Such an assessment may be conducted through various communication channels such as video calls or other appropriate tools available.
Also many inspectorates from EU and other regions of the world have started to utilise Distant Assessment approaches.
But it needs to be well-prepared from both, the auditor and the auditee.
Zielgruppe
GMP Inspectors and GMP Auditors from Pharmaceutical and API Industry and those who are involved in preparing and managing Distant Assessments, audits and inspections.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Approach and Expectations
- What are the regulations saying?
- Which inspectorates are currently performing distant assessments?
- Benefits, limits, risks
- Classification in the overall Supplier Qualification System
- Reliance of QPs on results of remote supplier audits for batch certification,
- Risk-based planning
- Which companies are suitable for a Distant Assessment?
Technical Background
- IT infrastructure
- Set-up of an online Meeting
- How to realise a safe document review
- How to realise a facility tour
- Data integrity
The Auditee’s Perspective
- How to prepare customer Distant Assessments
- Tools needed
- Which documents can be provided upfront – and how
- What problems can occur and possible solutions
- Resources and time requirements
The Auditor‘s Perspective
- Communication upfront
- Document exchange upfront
- Which areas are suitable for a Distant Assessment?
- Integration of remote auditing into the customer‘s QA System
- Experience made and lessons learned
How to Perform/ Host Internal Remote Audits
- Initial preparation and planning
- Fully paper based and hybrid approaches
- How to support a virtual tour
- Sharing of documents
Case Studies: Experiences made with Various Inspectorates
- How to prepare and manage Distant Assessments by inspectorates
- Russia (FSI SID&GP)
- Germany
Case Studies: Would you Find This in a Distant Assessment?
- How to make and rate observations
- Examples
Case Study: How to Assess a Site Master File from Distance
- When to ask for the SMF
- What to focus on
- What questions to ask
The Follow-up
- How to reply to report and observations
- Dissent and dispute
- Proof of CAPA effectiveness
- Ensuring that measures are implemented company-wide
- What to do if a target date cannot be achieved
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