Webinars

Deviation Investigation Best Practices:  Ensuring Correct Content and Conclusions

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
Fundamentals of Good Clinical Practice

Fundamentals of Good Clinical Practice

This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.
Food Safety and Security - Ensuring Food Safety from Farm to Fork

Food Safety and Security - Ensuring Food Safety from Farm to Fork

This food safety webinar will discuss the currently accepted food safety practices and how the the newly evolving system for food safety is about to be put in place.
Decision-Making and Human Error Prevention

Decision-Making and Human Error Prevention

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.
Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production

Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production

Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
The GCPs:  How to Implement for Compliant Clinical Trials

The GCPs: How to Implement for Compliant Clinical Trials

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
IRB Submissions Reviews and Approvals

IRB Submissions Reviews and Approvals

To establish that a drug or device is safe and effective, tests are required. There are many preliminary tests, including lab tests, standards, guidances, etc. Finally the product must be tried out on humans / patients in a tightly controlled environment. The clinical site(s) IRB Review is and FDA requirement and crucial to obtaining a site(s).
Understanding FDA and Health Canada

Understanding FDA and Health Canada

This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.
Technical Writing - Medical Devices - Writing Effective 510K, PMA, and De Novo Submissions

Technical Writing - Medical Devices - Writing Effective 510K, PMA, and De Novo Submissions

In a rapidly evolving medical landscape, the significance of meticulous and effective technical writing cannot be overstated. Join us for a enlightening 3-hour webinar, "Technical Writing for Medical Devices: Writing Effective 510(k), PMA, and De Novo Submissions," where we will delve into the intricacies of crafting comprehensive and persuasive regulatory submissions. From the foundational understanding of regulatory pathways to the fine art of presenting clinical data, this webinar will equip you with the tools and knowledge necessary to excel in this critical aspect of the medical device industry.
GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

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 and tools must change to meet these challenges.
Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark

Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark

To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.
Data Integrity And Human Error

Data Integrity And Human Error

Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle. Data integrity is crucial for any organization as it ensures that the data they rely on to make decisions is trustworthy and reliable. This topic discuss the importance of data integrity in regulated industries, such as pharmaceuticals and medical devices.
Understanding Supply Chain Management Concepts

Understanding Supply Chain Management Concepts

This presentation looks at the entire supply chain picture and the physical flow of materials and services, the flow of information, the flow of money, and the flow of people. Participants will review a successful supply chain process versus an unsuccessful process. The presentation will explore the benefits and challenges of this end-to-end process.
Supervisor Accountability and Responsibility for Employee Safety and Health

Supervisor Accountability and Responsibility for Employee Safety and Health

This webinar will look at some of the most prominent operative factors and define the norms in the Responsibility and Accountability architecture of management, namely the Supervisor. Because most business in the US is classified as ‘small business’, very often the luxury of having a system or process for supervisory selection and development is informal, at best. We will describe some of the easiest and most effective ways to bring a supervisor up to speed on their responsibilities. Some of these techniques are surprisingly simple.
Designing and Implementing an Effective Quality Management System (QMS)

Designing and Implementing an Effective Quality Management System (QMS)

Implementing a Quality Management System (QMS) involves a structured process to ensure consistent quality across an organization's operations. It typically starts with understanding the organization's context, defining policies and objectives, mapping key processes, and then implementing, monitoring, and continuously improving the system. The implementation process can vary based on the organization's size and complexity, but generally takes 3-18 months depending on an organization’s size.
AI, ML & FDA Compliance for Computer Systems & Data

AI, ML & FDA Compliance for Computer Systems & Data

During the webinar, we will discuss FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee. You’ll also learn about current and potential uses of AI in health care and the challenges posed. We’ll cover how and under what circumstances products relying on AI are regulated by FDA, and how to ensure benefits of products outweigh risks.
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
Dietary Supplements' CGMPs, 21 CFR 111

Dietary Supplements' CGMPs, 21 CFR 111

What are the U.S. FDA's requirements for marketing and selling dietary supplements / nutraceuticals in the US, including their QMS per 21 CFR 111.
Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.
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