Improve your Quality Reviews - Online Training Recording

Costs

*ECA-Member:**	EUR 1690,--
*Regular Fee:**	EUR 1890,--
*EU/GMP Inspectorates:**	EUR 945,--
*APIC Member Discount:**	EUR 1790,--
*QP Member Discount:**	EUR 1690,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Cheryl Chia, Lotus Phoenix Consulting, The Netherlands
Dr Rainer Gnibl, GMP Inspector for EMA, Germany
Dr Jean-Denis Mallet, NNE Pharmaplan, France
Dr Jens-Uwe Rengers, JeRo Consulting, Switzerland

Objectives

This Live Online Training examines regulatory requirements, provides insight into inspectors’ expectations and explains tools for improving your documented review processes.

Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.

Background

Quality Reviews and Metrics are critical GMP elements. They are an integral part of a pharmaceutical quality system and provide an opportunity to assess and control relevant processes.

Both parts of the EU-GMP Guidelines require the Product Quality Review (PQR) to verify the consistency and appropriateness of existing processes, but also to identify product and process improvement opportunities.

The FDA 21CFR 211 requires an Annual Product Review (APR) to evaluate annually the quality standards of each drug product.

All relevant guidance do also consider a Management Review to be an appropriate instrument to assess adequacy and effectiveness of quality systems.

All these different reviews could result in a tremendous work load or they can be performed in an efficient way with useful results – depending on how they are organised. Therefore, it is very important to understand the requirements and the idea behind it and to see how these tools can be used more efficiently.

Target Group

This Live Online Training is designed for managers, supervisors and all other staff members in the pharmaceutical and API industry who are involved in preparing and compiling Quality Reviews and Metrics.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programme

Quality Reviews in the Context of FDA, EU and ICH Requirements and Expectations

EU-GMP: which types of Quality Reviews are required?
EU Quality System Review (overview)
How to achieve EU-GMP compliance
ICH/US-FDA view on the situation (overview)
EU Product Quality Review (PQR)
- Technical terms and aims of PQR
- What documents and data should be reviewed?
- Are EU-requirements the same for APIs & medicinal products?
- What about US-FDA and ICH?

PQR and APR

How to combine PQR and APR in an efficient way
Well-proven PQR/APR designs
Interface to Regulatory Affairs
Certainties (PQR/APR in Custom Manufacturing, how to deal with limited numbers of batches …)

EU Product Quality Reviews in the Light of Inspections – Expectations of the Agencies

Inspectors view on critical parts of EU-PQR
Practical implementation and inspection
PQR and contract manufacturing
Comparison EU-PQR and US-APQR (inspectors point of view)

Discussion of given PQR-Examples
Based on real examples, the speaker will discuss the content and lay-out of PQRs:

What is useful?
What is ambiguous?
What could be improved?

Set up of efficient PQRs and APRs

How to use the data from existing systems (and vice-versa)
Best practices / filtering the data
Time/ efforts needed
Ongoing (computerised) data Collection
Possible difficulties and redundancies
Examples

Management Review

Definition, scope, objectives
Organisation
Participants, responsibilities
Topics to be presented: input and output
KPIs per system
Examples and experience

Using KPI in Quality Reviews and in Communication with Authorities

Current regulatory status of the expectations
Key areas and data to be submitted
The two communication levels: baseline and emergencies
How to get ready to communicate upon request

Quality Reviews in Contract Manufacturing

Customer QMRs - content, scope, frequency, organisation
Interface with Business Management Reviews
Assessment of data, trending and decision making
Actions, follow-up
„Face to Face“ or telecon?

Management Review - from Data Collection to Evaluation and Reporting

Collection and preparation of data: time/efforts needed, automatic vs. manual data capture
Evaluation of deviations and changes
Interpretation of data: what is the data telling us?
How to report the data and information gained

Review Management: Bringing them all together in an efficient Way

How to set up an integrated data, review and Report management
How to avoid double work

Recording from 10/11 April 2024

Duration of the recording: approx. 9 h 20 min

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