Webinars

Medical Device Process Validation Training for Professionals

Medical Device Process Validation Training for Professionals

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
GMP Compliance for Quality Control and Contract Laboratories

GMP Compliance for Quality Control and Contract Laboratories

This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.
US FDA Labeling Requirements for Medical Devices

US FDA Labeling Requirements for Medical Devices

The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
Pharmaceutical Data Integrity

Pharmaceutical Data Integrity

Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
Medical Device Change(s) and the 510(k)

Medical Device Change(s) and the 510(k)

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
Supervising a Human Error Free Environment: You can do a Lot More than you Think

Supervising a Human Error Free Environment: You can do a Lot More than you Think

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.
Good Laboratory Practices by Using The Quality Management System (QMS)

Good Laboratory Practices by Using The Quality Management System (QMS)

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.
Transfer of Analytical Methods according to USP <1224>

Transfer of Analytical Methods according to USP <1224>

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
Validation Sampling Plans

Validation Sampling Plans

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
Powerful Closed-loop CAPA - Meeting FDA Expectations

Powerful Closed-loop CAPA - Meeting FDA Expectations

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
Project Management for FDA-Regulated Companies

Project Management for FDA-Regulated Companies

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
How to Prepare for and Conduct a Regulatory Audit

How to Prepare for and Conduct a Regulatory Audit

In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the Covid-19 Pandemic.
FDA Ambitious Regulation of Social Media and Corporate Responsibility

FDA Ambitious Regulation of Social Media and Corporate Responsibility

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
HIPAA Audit and Enforcement Update for 2022 – HHS Keeps Pressure on Access, Privacy, and Security Compliance

HIPAA Audit and Enforcement Update for 2022 – HHS Keeps Pressure on Access, Privacy, and Security Compliance

This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.
Major CGMP Issues - US FDA Concerns in 2022

Major CGMP Issues - US FDA Concerns in 2022

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.
User / Human Factors Engineering Under IEC 62366-1, -2

User / Human Factors Engineering Under IEC 62366-1, -2

This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
CMS Two Midnight Rule

CMS Two Midnight Rule

The 2 midnight rule is designed to identify the appropriate level of care for short term stays or episodes in acute care, critical access and long term hospitals and to reimburse accordingly. The rule designed to save money by payment through Medicare part B instead of A is seen by many consumers and providers as both unclear and a cost shift from CMS to consumers and providers hence the controversy surrounding this rule. The presentation will provide history, explanation of the rule with both medical and financial outcomes and illustrate with case examples.
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