Live Online Training: QC Compliance Manager
Im Auftrag der ECA Academy

15/16 June 2021

Seminar Nr. 19015

All times mentioned are CEST.

Unser Seminarservice

Kosten

ECA-Member:	EUR 1590,--
Non ECA Member:	EUR 1790,--
EU/GMP Inspectorates:	EUR 895,--
APIC Member Discount:	EUR 1690,--

Alle Preise zzgl. MwSt.

Zur Anmeldung

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Thomas Backensfeld, Bayer AG, Berlin, Germany
Dr Raphael Bar, BR Consulting, Israel
Dr Thomas Fürst, Boehringer Ingelheim, Germany
Sue Mann, Sue Mann Consultancy, UK
Dr Bernd Renger, Bernd Renger Consulting, Germany

Zielsetzung

This Live Online Training will give a comprehensive overview of the main GMP requirements for quality control laboratories, from a European as well as from the U.S. (FDA) perspective. It is the aim of the course to address the challenges that QC Compliance Managers face today regarding the relevant regulatory requirements and how to successfully implement these requirements in the analytical lab.

Hintergrund

Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the U.S., for instance:

EU GMP Guide (Part 1 / Part 2 / Annexes)
21 CFR Part 210/211 (USA)
Guidances (EMA and FDA)
ICH Guidelines
WHO and PIC/S Recommendations
Pharmacopoeias (Ph.Eur., USP)

QC Compliance Managers must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.

In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the U.S.. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:

Change control systems
Calibration and qualification of analytical instruments
Reference standards
GMP compliant documentation
Validation of analytical methods
Stability program
Validation of computerised systems
Procedures for handling OOS results

All these key compliance issues will be addressed in this course and the main topics also deepened in Workshops.

Please note that the emphasis of this course is on small-molecule pharmaceuticals. The course will not focus on biotech products.

Zielgruppe

This Education Course will be of significant value to

Laboratory managers
Quality control managers
Analytical scientists
Senior laboratory staff

from quality control units in the pharmaceutical industry who are responsible for GMP Compliance in the analytical laboratory.

Technical Requirements

For our Live Online Training Courses and 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

Regulatory Requirements for Analytical Labs and QC (EU and US)

EU GMP Guide Part 1
EU GMP Guide Part 2
US 21 CFR Part 210/211
FDA Guidances for Industry with relevance for labs
Inspection of analytical labs (EMA, FDA, etc.)
FDA Warning Letters relating to QC

Handling and Qualification of Primary and Secondary Chromatographic Reference Standards

Procedure for qualification of a primary reference standard
Procedure for qualification of a secondary reference Standard
Pharmacopeial standards: handling and re-use
Will the certified reference standards (CRM) come to the QC lab?
Assigning purity values to reference standards
Calculation examples of assigning purity

Analytical Instrument Qualification

USP General Chapter <1058> Analytical Instrument Qualification
Risk Analysis
Qualification steps: DQ/IQ/OQ/PQ
Practical Qualification of typical instruments such as
- Balances
- HPLC
- UV
- Dissolution

Lifecycle Approach to Analytical Procedures

Developing robust, stability indicating methods
Analytical Target Profile
Implementation of QbD in development of analytical methods
Life-cycle of an analytical method
Are we estimating the real method precision?
The concept of Assay Format

Transfer of Analytical Methods

Definition and regulatory requirements
How to perform a method transfer
Case studies
Typical and critical issues

Presenting and Evaluating Stability Data

Overview of ICH storage programs for new drugs
Generic drugs
Presenting stability data
Derivation of shelf life according to ICH Q1E

Sampling of Raw Materials, Packaging Components, Devices and Finished Products

What is Acceptance Sampling?
Sampling of finished product and packaging
Sampling Attributes vs. sampling by variables
ISO 2859-1 sampling Standard
Nonconforming items and non-conformities
Classification of non-conforming items and non-conformities
Risks of sampling
Sampling of starting materials (WHO standard)
Full testing vs. testing for identity

Managing Out of Specification and Out of Trend Results

OOS / OOE / OOT
FDA and MHRA Guidance
Reportable Value
Case Study: Practical approach for handling OOS results
Issues with OOT results and how to manage these

Documentation in QC Laboratories

Regulatory requirements (EU / US)
Specifications, Test Procedures, SOPs, etc.
Handling of data (paper, electronic, hybrid)
Laboratory Data Integrity
Analytical results (Raw data, Raw data check, averaging, rounding of results)
Case Studies
Laboratory Data Integrity issues related to documentation - issues to be aware of

Analytical Aspects of Laboratory Data Integrity

Overview of deficiencies in laboratory data integrity
Structure of a typical assay in a QC laboratory
When system suitability requirements are not met
Is there a system suitability test based on samples?
When sample variability criteria are not met
QC samples for method validity check
Integration of chromatographic peaks: Automated versus Manual
Reprocessing of raw data and re-integration
Accepting or invalidating test results?
Review of audit trail of an analytical run

QA Aspects in QC (relevant for QC Compliance Managers)

Defining responsibilities for analysts, head of analytical lab, QPs (EU and US)
Release of APIS, excipients, packaging materials, finished products, etc.
Contract labs
CAPA (Corrective Actions and Preventive Actions)
Change Control (regulatory framework)
PQR
Training (GMP training / training on the job, training records)

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Live Online Training: QC Compliance ManagerIm Auftrag der ECA Academy