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Step-by-Step Process for Successful Sterility Failure Investigations
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of […] -
Measurement, Analysis, and Improvement for safe and Effective Medical Devices
This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness. This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage […] -
3-Hour Virtual Seminar on GCP ICH E6 R2 Addendum and Impact on Selection and Managing Vendors in Clinical Research
FDA Regulations and the updated ICH E6R2 addendum note more expansive requirements for vendor oversight including quality systems and risk management awareness. This does not mean after signing the contract, your team finds out they are not compatible with the vendor or the vendor cannot provide the full services needed for the study. The sponsor […] -
Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This webinar will help you […] -
21 CFR Part 11 Compliance for Electronic Records and Signatures
Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting […] -
FDA’s 21 CFR Part 11 Add-on Inspections
Medical devices software have become integral and indispensable in the controlling, running and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics or dietary supplements industries. 21 CFR Part 11 addresses all electronic records; hence many of these applications that feed into cGMP data acquisition and records come under its purview. Foraging […] -
3-Hour Virtual Seminar on Human Error Prevention in the Life Sciences
This 3-Hour virtual seminar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. It will also address how human error occurs in the planning and execution stages of […] -
Biosafety and Blood borne Pathogen Safety in the Lab
The Centers for Disease Control and Prevention (CDC) has created regulations and guidelines that are recommended while working with biological materials, specifically, with blood borne pathogens. Join this webinar as we review these guidelines. Join in this webinar as we review how best to approach biosafety. We will also discuss how to implement an effective […] -
Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances
How would you approach a non-conformance in the laboratory? Do you start treating the symptoms right away? Or, do you take a moment to analyze and consider if there’s actually a deeper problem that needs your attention? Root Cause Analysis (RCA) is one of the most commonly used techniques that helps people answer the question […] -
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 end deliverables of the Supplier Quality Management Process which feed into the manufacturing line. More precisely, […]
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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...