Quality Control Compliance Manager

Quality Control Compliance Manager

Copenhagen, Denmark

Course No 9076


Costs

This conference already took place.

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

Speakers

Dr Raphael (Raphy) Bar, BR Consulting, Israel
Eric De Maesschalck, UCB, Belgium
Sue Mann, Sue Mann Consultancy, UK
Dr Kerstin Pauli, Bayer HealthCare Pharma AG, Germany
Dr Alexander Pontius, Bayer HealthCare Pharma AG, Germany

Objectives

This Education Course 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.

Background

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 US, 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 US. 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 instrument
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.

Target Group

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.

Programme

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
Sue Mann

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 spectrophotometer
- Dissolution apparatus
Dr Alexander Pontius

Sampling
EU GMP Part 1, Chapters 4, 5, 6
EU GMP Part 2, Chapter 7 (7.1 – 7.5)
EU GMP Chapter 4
Statistical sampling – requirements and interpretation
EU GMP Annex 8
EU GMP Annex 19
US / FDA Requirements
WHO
PIC/S
ISO (former Military Standard)
Sue Mann

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
Sue Mann

Analytical Methods: Development and Validation
Developing robust, stability indicating methods
Implementation of QbD in development of analytical methods
Life-cycle of an analytical method
Dr Raphael (Raphy) Bar

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
Dr Raphael (Raphy) Bar

Out of Specification Results
OOS / OOE / OOT
FDA and MHRA Guidance
Reportable Value
Case Study: Practical approach for handling OOS results
Sue Mann

Computer Validation in Analytical Labs
Regulatory requirements (EU Annex 11 / US 21 CFR Part 11)
GAMP / GAMP Laboratory Guide
PIC/S Guide Computerised Systems in GXP Environments
Validation of Excel spreadsheets
UCB Case Study: Implementation of a computerised system at UCB from IT infrastructure components to final VSR and periodic review
Eric De Maesschalck

Stability Testing
Overview of ICH storage programs for new drugs
Generic drugs
Mean kinetic temperature
Presenting stability data
Derivation of shelf life
Dr Raphael (Raphy) Bar

Transfer of Analytical Methods
Regulatory Requirements (EU GMP Chapter 6 Draft, WHO recommendations, USP General Chapter <1224>)
ISPE Guide
Case Studies
Dr Kerstin Pauli

Method Comparison – Equivalence Testing of Two Methods
Is a newly issued pharmacopeial method equivalent to an in-house validated and practiced method?
Dr Raphael (Raphy) Bar

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)
Sue Mann

Four Workshops

Some of the most important laboratory compliance topics will be further discussed in interactive workshops:

Topic I: Analytical Instrument Qualification
Moderator: Dr Alexander Pontius

Topic II: Validation of Analytical Test Procedures
Moderator: Dr Raphael (Raphy) Bar

Topic III: Method Transfer
Moderator: Dr Kerstin Pauli

Topic IV: Sampling of Raw Materials, Packaging
Components, Devices and Finished Products –
Practicing with the Sampling Standard ISO-2859-1
Moderator: Dr Raphael (Raphy) Bar

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