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3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union’s MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents’ differing purposes / goals, as […] -
Layered Process Audits for USFDA Regulated Industries
How can this new internal inspection tool – the Layered Process Audit (LPA) – be used to assist in FDA regulatory compliance, and in meeting requirements for an annual internal cGMP system audit / inspection. Each year companies are to perform a complete review /inspection / audit of their quality management system and its ability […] -
3-Hour Virtual Seminar on Successful Deviation Investigations
This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus on how to avoid the drawbacks that may occur during FDA inspections. We will also discuss […] -
CE Marking in the EU – Latest Regulations
The letters ‘CE’ appear on many products that are traded on the single market in the European Economic Area (EEA). CE marking is required for many products. CE marks: Show that the manufacturer has checked that their products meet EU safety, health or environmental requirements Are an indicator of a product’s compliance with EU legislation […] -
Successful Change Control Management
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Areas Covered in the Session : Overview of Change Control Regulatory Requirements What […] -
How To Reduce Human Error Once And For All – Investigations, Root Cause Determination and CAPA Effectiveness
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN […] -
FDA Regulated Mobile Medical Apps as Devices and Cybersecurity Explained
This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA cybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance. The FDA Guidance explains how they intend to […] -
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This seminar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report […] -
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Does your DHF remediation process resemble the very mess that it is trying to resolve? The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards. While it is retrospective in nature, it is the end result of a process that begins […] -
Selecting Right Statistical Tools to Solve Problems
Many pharma and biotech professionals and regulators point out that statistics is a necessary tool and yet many pharma organizations do not make proper use of the tool. Many of the reasons for the slow adoption of statistical thinking and methods in the past are no longer relevant today (Hoerl and Snee 2012). The Internet […]
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Recording Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Does your DHF remediation process resemble the very mess that it is trying to resolve? The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards.... -
Recording Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration
Does your Supplier Quality remediation process resemble the very mess that it is trying to resolve? Receiving Inspection (RI) and First Article Inspection (FAI) may appear to be the beginning of the manufacturing process. In fact, they are the... -
Recording Writing Followable Procedures – Avoid Procedure Related Deviations
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
Recording 3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording Effective Genotoxic Impurities Assessment In Drug Development
Residual impurities resulting from the synthetic route, the formulation, or from the degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be administered to patients. Some of these impurities may present... -
Recording How Will FDA’s New Approach to CSV Make Implementations Easier?
There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles... -
Recording Remote Auditing for Medical Device Companies
Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID-19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to... -
Recording Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System
This webinar will examine the basic elements of the EU’s QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical... -
Recording 3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording 3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers....
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Recording
3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019
Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while... -
Recording
3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions
This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities.... -
Recording
3-Hour Virtual Seminar on Design Controls for Medical Devices
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers.... -
Recording
3-Hour Virtual Seminar on Project Management for Computer Systems Validation
Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are... -
Recording 3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices
FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for... -
Recording
4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions
US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that... -
Recording 3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start... -
Recording 3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used... -
Recording 4-Hour Virtual Seminar on Preparing and Submitting Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications, and Conducting FDA Meetings
A key role is played by what you submit to the regulatory agency, they hold more than just written applications. They also enclose systematic tracking, editing, publishing and strategy of crucial data. Through precise instructions, case studies and first... -
Recording 3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process
Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of...