FDA Compliance
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510(k) and PMA Refuse to Accept Policy
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated,... -
510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the... -
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.... -
6-Hour Virtual Seminar on Adaptive Design for Clinical Trials
Duration: 6 Hours
Presenter: Elaine Eisenbeisz -
6-Hour Virtual Seminar on Annual Product Quality Reviews – Preparation, Reports, Impact of Latest Quality Metrics Guidance
Product Quality Review and Annual Product Review are the favorite documents for the inspectors and QPs. This pandemic is impacted on auditing also. Many regulatory agencies are planning audits based on risk-based approach. The Annual Product Quality Review (APQR)... -
6-Hour Virtual Seminar on Computer System Validation for Cloud and COTS Applications
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices... -
6-Hour Virtual Seminar on Good Clinical Data Management Practices
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support... -
6-Hour Virtual Seminar on GxP and the Quality System
GxP is the heart and soul of how we do business in regulated industries. GxP is a general abbreviation for the “good practice” quality guidelines and regulations. The “x” in the term stands for the various aspects of good... -
6-Hour Virtual Seminar on Introductory Pharmacology for Non-Clinical Professionals
This course is designed to introduce basic pharmacology concepts which are utilized in drug development and clinical research to non-clinical professionals. Topics will include the basic principles of pharmacology and overview of several major classes of therapeutic agents, with... -
6-Hour Virtual Seminar on QbD and Technology Transfer Program – A Practical Approach to Successful Implementation
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Quality needs to be built in to the product at design stage. So, we... -
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
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... -
A to Z of Supplier Management in the Medical Device Industry
Supplier management is an integral part of any quality system in regulated industries. Quality System regulation (QSR) and ISO 13485 have specific supplier management requirements that you are answerable to. FDA is getting more rigid about supplier audits and... -
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... -
Adequate 510(k) Preparation Could Save Significant Resources – Dos and Don’ts
This seminar is intended to help medical device industry exercise best judgment when preparing for premarket notification for submission to the FDA. This webinar will provide great opportunities to get familiar with FDA policy and guidelines on how...
