FDA Compliance in Analytical Laboratories - Online Training Recording
Course No. 20058A
Speakers
Jörg Kastenschmidt
Merck Healthcare
Dr. Joachim Ermer
Ermer Quality Consulting
Dr Manfred Fischer
Manfred Fischer Consulting
Dr. Bob McDowall
R.D. McDowall Ltd.
Objectives
This Live Online Training provides a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Guide, etc.). You will get to know
FDA’s expectations in analytical laboratories and related Areas
The essentials of documentation for QC Labs
How to calibrate and qualify analytical instruments in QC
What has to be considered regarding validation and transfer of analytical procedures
How to handle reference standards and reagents
This training provides guidance about how this all can be managed effectively.
Background
A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control laboratories particularly the handling of Out of Specification results.
As a result of the increased and on-going scrutiny of analytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly:
General cGMP understanding and particularly relating to compliance with written procedures
Validation, performance and transfer of analytical procedures
Data integrity
Management of out of specification and suspect test results
Instrument qualification including an explanation of the new version of USP <1058>and calibration
Computer validation (including the requirements and actual interpretation of 21 CFR Part 11)
Operator training
Management of reagents and standards
Take advantage of this course to discuss all these issues.
Target Group
This Live Online Training will be of significant value to:
All quality control managers responsible for FDA compliance in their laboratories
Senior laboratory staff charged with meeting these requirements day-to-day
All support staff involved in FDA inspections in their companies
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
General Aspects: Regulatory Requirements and FDA Inspections
Regulatory Overview (US, Europe and the world)
Regulatory requirements in the US (cGMP, CFR, Guidances for Industry, etc.)
FDA Inspections
Key issues during laboratory inspections
483s and Warning Letters
Sampling in Compliance with FDA Requirements
Importance of the sampling procedure
Regulatory requirements
Sampling statistics / sampling plans
Sampling procedures
Sampling equipment and environment
Training
Retained samples
FDA Approaches to Laboratory Data Integrity
FDA laboratory observations: falsification and fraud
Compliance Program Guide 7346.832 on Pre-Approval Inspections: Objective 3 - Laboratory data integrity
FDA inspector training: focus on the computer system not paper printouts
What controls do you need to have in place to ensure data integrity?
Documentation for Quality Control Laboratories
“Scientifically sound” GMP requirements of QC documents and approaches
Types of QC laboratory documents:
Test specifications and analytical procedures
Standard Operating Procedures
Instrument qualification protocols
Complete data for analytical testing and Certificates of Analysis
Compare and contrast FDA and EU documentation requirements
Management of blank forms and data integrity issues
Qualification of Analytical Instruments in the QC
Legal requirements (cGMP, CFR, etc.)
USP General Chapter <1058> Analytical Instrument Qualification
Testimonials