Speakers

Dr Jean-Denis Mallet

Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS

Katja Kotter

Vetter Pharma-Fertigung

Dr Anke von Harpe

QProgress

Dr. Rainer Gnibl

GMP Inspektor, Regierung von Oberbayern

All times mentioned are CET.

Objectives

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.

Background

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.

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.

Target Group

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.

Programme

Live Online Training: Distant Assessments/ Remote Audits - what you need to know

Seminar Programme as PDF

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

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

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Further dates on-site

Further dates on-site
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Further dates online

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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Live Online Training: Distant Assessments/ Remote Audits - what you need to know