This Live Online Training 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.
Objectives
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 training 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 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 need to be familiar with all these GMP-related topics and need to 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 Instrument
Reference Standards
GMP compliant documentation
Validation of analytical methods
Stability program
Laboratory Data Integrity
Procedures for handling OOS results
All these key compliance issues will be addressed in this Live Online Training. A set of live Q&A sessions will give you the possibility to interact with the speakers and get answers to your Questions.
Please note that the emphasis of this training is on small-molecule pharmaceuticals. The course will not focus on biotech products.
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
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 Packaging Components, Devices and Finished Products / Sampling of Raw Materials
What is acceptance sampling?
Sampling attributes vs. sampling by variables
ISO 2859-1 sampling standard
Nonconforming items and non-conformities
Risks of sampling
Sampling of starting materials (WHO standard)
Full testing vs. testing for identity
Workshop on Sampling with ISO 2859-1
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
Reprocessing of raw data and re-integration
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)
Further Information
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 events 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.
Fees (per delegate, plus VAT) ECA Members EUR 1,890.- APIC Members EUR 1,990.- Non-ECA Members EUR 2,090.- EU GMP Inspectorates EUR 1,045.- The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
