Improve your Quality Reviews & pre-course session Statistical Process Evaluation and Reporting

Improve your Quality Reviews & pre-course session Statistical Process Evaluation and Reporting

Vienna, Austria

Course No 15585


Costs

Non-ECA Members: EUR 2290,--
ECA Members: EUR 1990,--
EU GMP Inspectorates: EUR 1145,--
APIC members: EUR 2190,--
QP Association Members: EUR 1990,--

(All prices excl. VAT)

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

Speakers

Dr Rainer Gnibl, GMP Inspector for EMA

Prof Edwin van den Heuvel, University of Technology Eindhoven

Dr Anja Keubler, AbbVie

Dr Andreas König, Aenova Holding

Katja Kotter, Vetter Pharma-Fertigung

Objectives

This course examines regulatory requirements, provides insight into inspectors’ expectations and provides 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.

Now, the U.S. FDA has set up an initiative to use Quality Metrics for risk based inspection planning and published a draft Guidance for Industry in July 2015 and a Technical Performance Guide in June 2016.

All relevant guidances 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 Education Course 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.

Every participant will get:

  • an example for a PQR SOP with Annexes
  • an example for a Management Review SOP
  • real PQR examples
  • extracts from real Management Reviews

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?
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)
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 …)
Set up of efficient PQRs and APRs
  • How to profit from existing QA Systems in PQR/APR and vice versa
  • Best practices
  • Time/efforts needed
  • Ongoing data collection
  • Foreseeable complications/advantages
  • Well-proven examples
Workshop: Evaluation of given PQR Examples
Evaluate with other delegates the content and lay-out of given PQR examples and discuss it with the speakers
  • What is useful?
  • What is ambiguous?
  • What could be improved?
Management Review
  • Definition, scope, objectives
  • Organisation
  • Participants, responsibilities
  • Topics to be presented: input and output
  • KPIs per system
  • Examples and experience
Vetter Case Study: 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?
AbbVie Case Study: From Data Collection to Evaluation and Reporting
  • Collection and preparation of data: time/efforts needed, automatic vs. manual data capture for CQAs, IPCs, product yield
  • Evaluation of deviations and changes with potential impact on process/ validated state
  • Evaluation of root causes related to the process
  • Interpretation of data: what is the data telling us?
  • Validation status assessment: from process capability to confirming the state of control )
  • Special topics: tracking and trending of dissolution data, handling of low volume products, data storage
How to manage the new FDA Requirements on Quality Metrics
  • Current status of the requirements
  • Key areas and data to be submitted
  • How industry can prepare to meet the expectations
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

Pre-course Session „Statistical Process Evaluation and Reporting“ on 17 May 2017

This pre-course session will provide you recommendations, tools and examples to apply statistical principles in your day-to-day business as well as to meet future challenges.

Working with statistical simulation tools, you will gain understanding of the consequences of appropriate and inappropriate performance parameters and a sound evaluation of data.

The Application of statistical Tools in Data Review
Introduction
  • Ongoing/data collection and management
  • Interpretation, comparison and presentation of data
  • Describing process capability and performance
  • Control Charts; what is a trend and how to deal with it?
  • Quality Metrics
  • Documenting the outcomes; are we in control?
Quality Review Summary Report
  • Descriptive Statistics
  • Outlier detection
  • Normality testing
Quality Review Performance
  • Control Charts
  • Capability Indices

The Session includes a Workshop with Minitab Software: What are the Data telling us?
A case study on analysing and interpreting process performance data.

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