-
Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance
This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a […] -
Equipment Qualification and Process Validation
Equipment qualification and process validation is a cumbersome activity if realistic but compliant approach is not applied. This session should help responsible personnel and teams to apply efforts in right direction to ensure regulator satisfaction at the same time help company operationalize full potential of both process and equipment/system. Lack of adequate qualification or validation […] -
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 […] -
Handling OOS Test Results as per Latest FDA Guidance – 2022
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 area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical […] -
New Drug Applications (NDA’s), Investigational New Drugs (IND’s) and the Drug cGMP’s
The regulation and control of new drugs for sale in the US is based on the NDA and the IND development and clinical process. Manufacturing of drugs must be under the Drug cGMPs, 21 CFR 210/211. For decades, the regulation and control of new drugs in the United States has been based on the New […] -
Introduction to Design of Experiments
Design of Experiments (DOE) is an important technique for root cause analysis (RCA) and process improvement. As an example, when potential trouble sources are identified from a cause and effect diagram, DOE can be used to determine which of the factors are likely to be important. DOE can also develop quantitative models of the nature […] -
How To Implement An Effective Human Error Reduction Program
Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site. Why You Should Attend: If you work in the GMP regulated industry you not only need to address human error deviations […] -
FDA Compliant QC and QA Practices – Creating a Perfect, Audit-Ready QMS
In the pharmaceutical world, the term “quality” has several definitions. Generally speaking, quality means the product is fit for its’ intended use, is free from defects, and meets or exceeds customer expectations. The general public assumes manufactured pharmaceutical products are safe, efficacious, and have the correct identity. The Quality Control and Quality Assurance units within […] -
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
One of the most useful analytical methods for cleaning validation studies is Total Organic Carbon (TOC). This includes the design, qualification and routine monitoring of the manufacturing process. While there does exist some confusion within the industry and regulatory bodies about the use of this analytical technique, it is widely used because of its assured […] -
How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records
This course is intended to provide specific guidelines for coaching attendees in the concepts of 21 CFR Part 11, namely the FDA requirements for using electronic records and electronic signatures (ER/ES), and the best practices for implementing these technologies in a regulated environment. The use of electronic records and signatures enables a company to conduct […]
-
Recording GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Various firms are subject to various relevant and applicable federal regulations including, but not limited to, Good Laboratory Practice (GLP), Current Good Manufacturing Practice (cGMP), and Good Clinical Practice (GCP). It is important for the industry to accurately understand... -
Recording
Data Integrity for the Laboratory and Beyond
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid... -
Recording
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud
Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application... -
Recording
Good Clinical Practices Review of ICH E6
The webinar will establish the foundation for this subject by defining GCP and discussing GCP in relation to its historical perspective. The thirteen core principles of GCP are essential to understanding how GCP is structured and expected to be... -
Recording
How to Deploy Root Cause and CAPA to Minimize Human Error
Many variables, from procedures, to training to workplace environment, affect human behavior. You need to understand human behavior and the psychology of error in order to implement a process dedicated to investigating and fixing human errors. Human Error Solutions’... -
Recording
Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training
This webinar will discuss the key features involved in setting up / building your Quality Management System (QMS) so you are ready for FDA and other supplier/ISO certification related audits. Manufacturers of FDA regulated products such as medical devices,... -
Recording
FDA Audit Best Practices – Do’s and Don’ts
The FDA has been increasing its surveillance of regulated industries. While it is a given that companies must meet their regulatory requirements, how company staff handle an audit and interact with FDA inspectors, can mean the difference between a... -
Recording
Excel Spreadsheet Validation In GxP Environment
This training will help all the candidates about what are the requirements about excel sheet validation, how to perform excel validation and ensure compliance in the organization etc. At the last, we will have brain storming session with Q&A... -
Recording
Process Capability vs Process Performance – Understanding the Practical Difference in line with FDA expectations
Every company wants to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most... -
Recording
Equipment Qualification and Process Validation
Equipment qualification and process validation is a cumbersome activity if realistic but compliant approach is not applied. This session should help responsible personnel and teams to apply efforts in right direction to ensure regulator satisfaction at the same time...
-
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)... -
Recording
6-Hour Virtual Seminar on Statistics for Quality Control
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information... -
Recording
2-Hour Comprehensive Seminar on Measurement Systems Analysis
Attendees will also receive an Excel spreadsheet with the d*2 factors that are required for the average and range method, and another with data for the worked examples. These appear in some references that are named in the handout,... -
Recording
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... -
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....
