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... -
505(b)(2) New Drug Applications (NDA’s) – 3 Hour Virtual Seminar
NDAs submitted under FD&C 505(b)(2) are a those for which the product is not a generic nor a traditional brand. Learn the requirements for studies, reference information, and marketing requirements to take advantage of this great sponsorship opportunity. NDAs... -
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 – 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.... -
A Bulletproof, Cost-Efficient Supplier Management Program
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company’s purchasing and supplier control requirements provide the assurance... -
Additive / 3D Printing Manufacturing and Its Regulatory Issues
Additive Manufacturing (AM) or 3D Printing for manufacturing of medical devices is a new and rapidly expanding field, with rapidly expanding regulatory concerns. What is it? What are US FDA stated concerns? This webinar will focus on the key... -
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... -
ANDA Submission and GDUFA Final FDA Guidance
Just as everyone was beginning to get conversant with GDUFA’s confusing three-tier system, the FDA, on July 4, 2018, finalized the GDUFA II guidance! The final guidance simplifies the designation of amendments into two broad categories—Standard or Priority—while classifying... -
Annex 1 Manufacture of Sterile Medicinal Products
Knowing and applying the GMP regulations is one of the key elements in the manufacture of medicinal products, particularly in the manufacture of sterile medicinal products. Major changes have recently been made to the EU GMP guideline covering manufacture...
