21 CFR Part 11 – Complete Manual For Compliance Success

Apr 07, 18 21 CFR Part 11 – Complete Manual For Compliance Success

21 CFR Part 11 – Complete Manual For Compliance Success – Webinar By Globalcompliancepanel

Summary: FDA inspectors are increasing the amount of inspections where they include Component 11 as part of the scope or THE scope of the inspection. The trends and reviews are displaying that the FDA inspectors are concentrating on digital signatures and electronic information as increasingly more businesses are applying systems and technologies to aid these activities.

The amount of warning letters is increasing proportionally and we as quality and additional professionals using the technology and systems to aid our companies are not ready – we aren’t prepared to prepare and host FDA inspections when Part 11 is in scope, we are uncertain how exactly to best use and implement Audit Trails and certainly we’ve challenges with internal and external auditing for Part 11 compliance. This webinar address each one of these topics and you with a lot HOW EXACTLY TO we as auditors and inspectors boost our comfort and ease with the regulation, using its components and compliance and virtually implement audit program and audit trails – specifically since Audit Trails play main role partly 11 compliance – they could be your very best close friends and/or worst enemies simultaneously.

Areas Covered in the Seminar:How exactly to Prepare and Sponsor FDA Inspections (covers elements and information on planning for the inspection and also components of the successful methods of hosting an FDA inspection when Component 11 is in scope or the scope of the inspection. We may also cover some generally asked queries by the inspectors and great things about being compliant)

Internal and Exterior Auditing for Part 11 Compliance (this subtopic includes most areas of auditing for Component 11 compliance- beginning at the audit program level and going straight down on how to plan an audit to how exactly to successfully execute the audit and follow-up on the finished audit. This subtopic also contains CAPA and responses for the audit results linked to Part 11 – what things to expect and deal with the difference between “regular” audits and Part 11 audits. We include a few of the common audit results and common pitfalls and also tools for an effective preparing and execution of the audit.)

Audit Trails (includes types of audit trails, approaches for implementing complaint audit trails, proms and negatives of audit trails, how exactly to use audit trails while an audit tool through the internal and exterior audit and also through the FDA inspection check out, a few examples of “should” and “shouldn’t” with regards to the audit trails and commonly asked queries linked to audit trails.)

Overview and Knowledge of the Regulation (addresses topics such as for example introduction and advancement of the regulation, what things to expect later on with regards to the regulation, choices for (non)compliance, “what ifs”, and also most impactful sections and subsections of the rules.)How Component 11 Regulation Pertains to Other Rules (this subtopic compares the Component 11 regulation with additional regulations concentrating on commonalities so you and your business can easily see how easy/hard is to recognize gaps and also how harvest the reduced hanging fruits when striving to adhere to Component 11 regulation. We cover comparison with 3-4 other rules quoting the precise subsections of every.)

Sample Audit Questions (through the entire material, we make sure that we present you and prepare you to cope with some commonly asked audit and inspection queries. These queries are ready-made to work with when you as well as your group are conducting inner and/or external audits, however they are also ready-produced for you as well as your team to make use of as you prepare to/and sponsor FDA inspection when Component 11 in scope of the inspection. We consist of some of the queries in the material display and likewise to that we offer you with additional 30+ commonly asked questions record used for your references and schooling purposes.)

Trends; Warning Letter Illustrations; Advantages and Issues of the Regulation (we conducted research to enable you to get and your team outcomes of inspections and audits which have been executed in past many years. We include tendencies and graphs displaying how and where Component 11 rules impacts you the most, but may also show types of the caution letters which have been released in last many years due to insufficient compliance with the Component 11 regulation. Finally, we cover you need to include a few examples of advantages and issues you may be profiting from or facing to handle while striving to end up being Component 11 compliant.)

More (we discuss the importance and need for the regulation whether or not it (currently) pertains to you or not. We offer examples and HOW EXACTLY TO therefore that you as well as your team will get most from the materials and display – also to be capable to use it soon after attending this schooling/webinar.)

Who Will Advantage:Quality ManagersQuality EngineersManufacturing engineersCAPA investigatorsInspectorsSix Sigma specialistsConsultants

Tuesday, May 15, 201210:00 AM PDT 01:00 PM EDT