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Recording How to use Quality Systems Inspection Technique (QSIT) to Your Advantage
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at... -
Recording
3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know
With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative... -
Recording
Hypothesis Testing, P-Values, and Inference – When Thinking Like a Statistician Makes Sense
This webinar will present the reasoning that formulates null hypotheses and turns researchers’ hair gray. You will learn the why and how of the scientific method, and how to view the world with a statistician’s eyes. Do you become... -
Recording
The Transfer Of Validated Methods
This webinar will discuss the best practices of the transfer of validated methods including statistics of analytical methods, how to define universal methods, how to make the method operation uniform, training issues, and the use of transferring methods. Even... -
Recording
Handling Out-of-Trend Results in Pharmaceutical Quality Control as per Latest FDA Requirements
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA. FDA’s guidance on OOS test results... -
Recording
3-Hour Virtual Seminar on Design Control Essentials 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
Statistical Process Control (SPC) and Control Charts for Laboratory Compliance
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of... -
Recording
The Human Error Tool Box – A Practical Approach
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... -
Recording
3-Hour Virtual Seminar on Part 11 Data Integrity and Cybersecurity – The Latest Developments
Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized... -
Recording
OOS Test Results – Latest FDA Guidance
Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this...
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Recording
3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know
With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative... -
Recording
3-Hour Virtual Seminar on Design Control Essentials 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 Part 11 Data Integrity and Cybersecurity – The Latest Developments
Data integrity has always been a key component of all the cGMP’s, only now taking on greater emphasis due to the use of electronic records / signatures. Cybersecurity is the preventing the theft / modification of e-records by unauthorized... -
Recording
3-Hour Virtual Seminar on 510(k) and PMA Submissions Process
The FDA must review and process thousands of medical device submissions yearly. Shortening the time to market is a critical consideration of the medical device design and development process only after ensuring and affirming that the device meets its... -
Recording
3-Hour Certification Course on Good Manufacturing Practices (GMP) – An Introduction
Good Manufacturing Practices (GMP) are a cornerstone of life sciences production. In fact, this decades-old regulation is so important that nearly everyone from discovery through product production should have a working knowledge of it. Despite this, even those directly... -
Recording
3-Hour Virtual Seminar on cGMP Regulatory Inspections – Through the Eyes of FDA, EMA and PMDA
GMP-compliance is a must for manufacturers of finished pharmaceutical products and active pharmaceutical ingredients (APIs) according to the different national legislations. The related GMP rules are typically valid for one country based upon the anchoring in the respective national... -
Recording
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... -
Recording
3-Hour Virtual Seminar on Computer System Validation (CSV) vs Computer Software Assurance (CSA) – Following a Waterfall vs Agile Methodology
As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance... -
Recording
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... -
Recording
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)...
