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Clinical Quality Auditing
As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate […] -
3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course […] -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA […] -
How to Make Design Part of Your Product Development DNA
Getting your development team to move forward in a cohesive fashion can be hard. Engineers and designers can have different goals and methods during a development project. In this session we will explore ways to embark into design research work that will fuel the product development work down the road, and learn a few things […] -
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 […] -
Quality Risk Management Overview
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM. Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. In addition they will be able to identify key QRM terminology and recognize the four (4) […] -
4-Hour Virtual Seminar on Quality Control Laboratory Compliance – cGMPs and GLPs
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries – pharmaceuticals, biologics, medical devices, as well as foods and cosmetics – as well as the contract QC laboratories which service these industries. Lack of compliance can result in […] -
The 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 […] -
Steam Sterilization Microbiology and Autoclave Performance Qualification
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process. Sterilization process […] -
Sterilization of Pharmaceutical Products and Medical Devices
This topic will discuss the methods of sterilization to be used on medical devices and pharmaceutical products. Understanding the regulations pertaining to sterilization of products will help to decide with method to use for your product. The advantages and disadvantages of each will be discussed. Validation of each sterilization method will be discussed and how […]
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Recording Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Why You Should Attend Training programs have evolved through time. Human reliability or human error... -
Recording Virtual Site Audits for FDA Regulated Industries
How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites. Each... -
Recording Medical Device Cybersecurity and FDA Compliance – How to Avoid Your Medical Device Being Hacked
This seminar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the device could... -
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Recording ISO 14971:2019 Medical Device Hazards and Risk Management – All you need to know
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 FDA Regulation of Artificial Intelligence / Machine Learning
AI / ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance’s for years, however, AI/ML programs fall outside the scope of these regulations... -
Recording How to Prepare for and Host a FDA Inspection and Respond to 483’s
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock... -
Recording Blockchain Innovations that Connect and Protect the Supply Chain
This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s... -
Recording 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... -
Recording 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...
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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... -
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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... -
Recording 3-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and... -
Recording 3 Hours Virtual Seminar on Root Cause Analysis for CAPA Investigations
To ensure an organization’s quality system has a system to identify product and quality issues; the FDA mandates establishing a process for Corrective and Preventive Action. Any effective CAPA system must include the identification, documentation and review of root... -
Recording 3-Hour Virtual Seminar on Bad Standard Operating Procedures (SOPs) – Bad Training: Garbage In, Garbage Out
Standard Operating Procedures (SOPs) are necessary to demonstrate compliance with regulations and operational practices. It also serves as a documented roadmap which ensures consistency. This is integral to a strong quality system. If you want to improve SOPs writing...