FDA Compliance
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation... -
510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality... -
510(k) Update and Medical Device Changes
This webinar will provide valuable guidance to regulated companies on latest 510(k) updates and in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S.... -
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their... -
Advertising and Promotional Material Compliance and Review Process
The webinar will address requirements for compliance, “gray areas,” risk assessment, opportunities for input from regulatory agencies, and review process and procedures. This webinar will address issues of compliance in the creation of advertising and promotional materials and the... -
ANDA Approval Process Pursuant to GDUFA
The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration, same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug). In... -
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Are you ready for the next FDA inspection? – Inspection Readiness Preparation
Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist?... -
Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used... -
Auditing 101
The Course clarifies the role of the new auditor or internal auditor and explains their responsibilities. The session will also discuss interactions with others in key roles as part of the audit as well as exploring some techniques used... -
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Avoid Reporting Cybersecurity Updates and Patches to the FDA
Is a cybersecurity patch or update a reportable event under the Reports of Corrections and Removals regulation? (21 CFR Part 806) The FDA issued a guidance document recently entitled, “Postmarket Management of Cybersecurity in Medical Devices.” It explains that... -
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Basic Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
Best Practices in Preparation for an FDA Computer System Audit
The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and...
