This webinar will show you that there is no sense in tackling the 'keeping' of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records.
If you are part of the process of 'Collecting' (e.g.: from study nurse to x-ray specialist), 'Using' (e.g.: from sponsor to report programmer, or statistician), or 'Keeping' (e.g.: from coder, software provider, to server and backup specialist), then this webinar will answer the questions: of how important your part is in this process, and how you can help the company safe resources and be compliant.
If an effort is made to collect research-, study-, patient- or other important records, they should be kept safe, in a controlled and organized way. That way is defined by the requirements.
Why should you Attend
The cost of lost data/records can be staggering; also, the mishandling of records or lack of safekeeping. Withdrawing or the wish of deleting could be a big problem too.
It is not only about data or records but different samples as well which must be managed in the same way.
There is never 'one fits all' but the FDA's 21 CFR Part 11 is still perfectly usable after many years. The main reason for that is, that it points to the requirements of predicate rules.
You have to provide an assured level of quality right from the beginning of the process (collecting records); that at the end the inspector, with the Part 11 in hand, will find no negative observations.
Areas Covered in the Session
- Overview and Definitions
- The reasons why only talking about records or data is not enough
- The relationship between the owner or provider, the collector or user, and the keeper
- The forgotten loop
- Common mistakes and today's problems (including 'Big Data')
- Best practices or the ideal process
Who Will Benefit
- Clinical Operations Professionals (from study nurse to x-ray specialist)
- Clinical Quality Assurance Professionals
- Data Management Professionals
- Clinical Investigators and Clinical Investigator Site Staff
- Sponsors Clinical Study Groups
- Clinical Trial Statisticians and Statistical Programmers
- Clinical Electronic Systems Developers (also Big Data)
- Service Providers (for saving and maintaining any samples of importance)
Willi Ramseier, the Owner and the Director of QVRAM GmbH. A Well renowned Expertise in Quality assurance, system Validation, Risk -Awareness and risk-Management
Willi Ramseier is a reputed trainer, mentor and a Quality compliance officer.
He is an expert at Big Pharma company at Germany serving as Project and Process Guidance and Trainer being a Quality assurance and Compliance Officer.
Willi serves as a Process-Validation Expert at Synthes-dePuy-Johnston&Johnston Switzerland.
Quality Consultant for a CRO in Cologne; providing hands-on help with process- documentation, requirements creation, planning, CSV (computerised system validation). CSV auditing
He also involves himself completely in CAPA plan reviewing as a QA, and GxP Workshop Trainer for a CRO, Dresden
Willi aids the small companies on the new regulatory aspects. Mentoring the young quality-consultants, Start-ups companies. Early to his career as a consultant Willi has a good amount of management skills which certainly has helped him assisted him in all stages of his career so far.
Willi Ramseier’s areas of expertise:
eClinical, eCRF, Data Management
21 PART 11, electronic records and signature
Risk -awareness, -assessment, -management
Risks and hazards at logistics of human samples and drugs
CSV computerized system validation
GxP, Quality Assurance, System/ Process Validation
Creating and maintaining QMS quality management systems
Data flow in clinical trials, Process management
e.g.: DIA, cbi center for business intelligence, SMi Group, Arena-international, SAS Sweden, Roche -Global, -Basel, -Ireland.