FDA 21 CFR Part 11

OVERVIEW
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

• 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
• Questions
• Course Level - Overview of the relationship between the groups which take part in the process of providing, using and safekeeping of records and samples. The fundamental importance of requirements; who needs to provide them, and what they are used for.

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)

SPEAKER
Willi Ramseier is the pragmatic system thinker, project management skills, risk management know-how, expertise in CAPA system and QMS (quality management system), a consultant for general quality issues (especially for start-ups)

His assets :

Presenter, speaker, (SAS Stockholm; Allan Lloyd Amsterdam; DIA data Madrid, DIA Barcelona, ERES Roche)
Vendor Audits and Quality Reviews
Concepts for the quality management system, CAPA system, Change management, ISO9001:2015
Process management (Policies, SOP’s, SA entries, System Validation); Risk assessment and management; CAPA plans (create, review and approval); Equipment (inventories, qualification, validation); Documentation, Templates; Training (GxP, CSV, CAPA, Company rules, Project management methodology)
Variety of work :

IT projects (from quality assurance and validation to access concept and security)
Lab projects (pathology, CPU, DNA, RNA)
Clinical trial teams quality assurance (Report validation, endpoint adjudication, Web sites)
CRO’s (clinical research organization)

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