Dr. Jens-Uwe Rengers
vorm. Akorn
Referent:innen
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Cheryl Chia
Lotus Phoenix Consulting
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
All times mentioned are CEST.
Zielsetzung
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.
Based on real examples you will learn how you can implement and improve your Quality Reviews and use them more efficiently.
Hintergrund
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.
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.
Zielgruppe
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 Requirements
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
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:
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
Question and Answer Sessions
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
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