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3-Hour Virtual Seminar on Master Validation Plan – The Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V […] -
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 […] -
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 manifest in clinical trial execution. ICH E6 will be reviewed in detail as that guideline serves […] -
4-Hour Virtual Seminar on Aseptic Processing and Validation
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product […] -
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 of both. To assure the quality of raw materials, in process materials and finished goods, laboratory […] -
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 of critical thinking to identify how data flows through the business process and to proactively assess […] -
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 so that, we will able to trigger the thought process in candidates about putting controls on […] -
Project Management Utilizing Principles of Lean Documents and Lean Configuration
Project Management involves not only the management of tasks and task owners, but also of information involving documents, records, and many other elements. The traditional approach is to compile, create and push these through the various stages. The concept of critical chain project management draws from the concepts presented in the business novel Critical Chain […] -
Environmental Monitoring Investigation Techniques for Effective Contamination Control
This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that […] -
Using Metrics to Monitor and Improve Your Quality System
Medical Device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders: Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective products. Metrics that measure and trend product quality and customer satisfaction are critical. Fast or real-time […]
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Recording 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... -
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
Human Error and Management Systems – Designing Errors Out
If you work in the GMP regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR – Code of Federal... -
Recording
Deconstructing the EU MDR with Principles of Lean Documents and Lean Configuration
The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides... -
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
Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations
Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical... -
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...
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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)... -
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...
