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Webinars

Veterinary Medical Devices and FDA’s Regulatory Oversight

Veterinary Medical Devices and FDA’s Regulatory Oversight

This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
US FDA's Plan for Modernizing the 510(k) Pathway - Meet the New Expectations

US FDA's Plan for Modernizing the 510(k) Pathway - Meet the New Expectations

Almost two years ago the US FDA announced new steps necessary to modernize FDA’s 510(k) clearance pathway, but companies have been slow to respond, leading to unnecessary delay in achieving marketing clearance. This was reiterated one year ago in the FDA’s Medical Device Safety Action Plan and the related Draft Guidance Document. These steps are viewed by the Agency as a top priority, and provide insight into the Agency’s thinking about what a 510(k) could do to advance medical benefits to the patient.
Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.
Streamlining your QMS and Audit System for Remote Audits

Streamlining your QMS and Audit System for Remote Audits

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

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 is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
10 Tips for Successful Hospital Utilization Management: From Foundation to New Trends

10 Tips for Successful Hospital Utilization Management: From Foundation to New Trends

Attend this webinar to understand hospital utilization management despite demanding payers doing everything they can to deny payment through denial of medical necessity. Learn about the best model of case management, denial management, and best practices in clinical reviews.
Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification

This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
FDA Inspections: Understanding the Core Elements – Part I

FDA Inspections: Understanding the Core Elements – Part I

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

Attend this webinar to understand the changes of the new EU MDR 2017/745 regarding quality management, the EN ISO 13485:2016 and the EU MDR 2017, and how to implement the changes to fast track internal audit.
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
Preparing for a US FDA CGMP Compliance Audit Under 21 CFR 210, 211 and 820

Preparing for a US FDA CGMP Compliance Audit Under 21 CFR 210, 211 and 820

Recent US FDA Inspections ("audits") indicate the "c" in CGMP is a moving target – with expectations growing upward! In this webinar, learn how to use the FDA's inspection flow charts and questions, past inspections, and key elements of the CGMPs to prepare for an FDA GMP Compliance Inspection. Recognize that past results are not an accurate of future inspection results. You will learn how to incorporate industry findings into your gap analysis and remediation plan.
Spotlight on Complaint Handling and Medical Device Reporting

Spotlight on Complaint Handling and Medical Device Reporting

This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.
Will your food fraud vulnerability assessment pass an audit?

Will your food fraud vulnerability assessment pass an audit?

The webinar will provide you with valuable information about setting up a food fraud vulnerability assessment so that you are better prepared to meet the food fraud-related requirements of GFSI Certification Programme Owners and the economically motivated adulteration requirements of the U.S. Food Safety Modernization Act.
The Mindset of an FDA Employee

The Mindset of an FDA Employee

If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry

Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry

Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Solving Statistical Mysteries - What Does FDA Want?

Solving Statistical Mysteries - What Does FDA Want?

This webinar provides some practical and useful answers to the question
What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?
FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.
Medical Device: Risk Assessment and Mitigation through FMEA

Medical Device: Risk Assessment and Mitigation through FMEA

This 90-minute presentation will discuss a structured way to mitigate risks with minimum cost. You will learn how to use FMEA to effectively estimate and assess risks in your medical device.
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