Sprecher
Dr Bob McDowall, Member of the ECA IT Compliance Interest Group
Zielsetzung
Hintergrund
In March 2015, also MHRA issued an updated Data Integrity Guidance containing an expansion of the expectations of Data Integrity governance together with a list of 19 definitions and expectations for each one. Followed in July 2016 by a more general guidance for GXP data integrity.
In June 2016, the World Health Organisation issued a final version of a guidance document which provides a more encompassing explanation of Data Integrity and also data governance expectations for regulated healthcare companies. EMA and PIC/S both issued draft Data Integrity guidance documents in August 2016. ECA have published two versions of Data Governance and Data Integrity guidance in 2016 and 2018. The GAMP Forum has published a Guide on Records and Data Integrity in 2017 and the first of three Good Practice Guides on Data Integrity - Key Concepts. Lastly, PDA has also issued a guidance document for pharmaceutical laboratories in August 2018.
The emphasis of all regulators is on the ALCOA principles to outline regulatory expectations for ways to ensure the integrity of data over the life cycle.
Zielgruppe
- Managers and scientists from Quality Control and Analytical Development Laboratories wanting to understand the Data Integrity and audit process
- Quality Assurance personnel
- Contract Research Organisation and Contract Manufacturing Organisation laboratory and QA personnel
- Auditors (internal and external) responsible for assessing laboratory quality and Data Integrity
Technical Requirements
For our 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
EU and FDA GMP Regulations Impacting Laboratory Data and Results
- EU GMP requirements
- MHRA and WHO Data Integrity Guidances
- FDA GMP requirements
- FDA Guidance documents OOS, Inspection of QC labs
- Inspection findings 483 and warning letters
- Defining Data Integrity, “complete data” and „raw data“
- Observational tests and instrument tests
- Training of staff
- Qualified analytical instruments and validated software
- Integrity issues
- Application of ALCOA+ principles
- What are the requirements for raw data integrity?
- Three scenarios covering
- a paper system
- a hybrid system
- a client server electronic system
- Paper / hybrid based systems
- Networked systems with electronic records and
- signatures
- Calculations and transformation of data manually and by computer applications
- Application of ALCOA+ principles to the process
- Calculating the reportable value and comparison with the specification
- Paper processes versus electronic processes
- Linkage with out of specification investigations (OOS)
- Reviewing an analytical record
- Scenario covering paper-based record and an electronic system
- Role of the second person review
- Determination that the reportable result is correctly calculated
- Identification and correction of errors for paper and electronic systems
- Do you have complete data?
- Application of ALCOA+ principles for the review of paper records
Key Learning Points and Final Q & A Session
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