Webinars

Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

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 particularly useful.
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
You have a BI Positive or Product Sterility Positive - Now What?

You have a BI Positive or Product Sterility Positive - Now What?

This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation.
GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

GxP/GMP Requirements and its Consequences for Documentation and Information Technology Systems

Attend this webinar to learn the connection between GxP/GMP with document control and IT systems. Attendees will learn how to manage control documents to pass quality audit and information technology systems in compliance with GxP/GMP requirements.
Validation Master Plan - The Unwritten Requirements

Validation Master Plan - The Unwritten Requirements

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, 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.
EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

EU IVDR 2017/746 - the new EU regulation for invitro diagnostic

Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.
Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.
Changes in the upcoming Standard ISO 14971:2019

Changes in the upcoming Standard ISO 14971:2019

The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.
Food Safety Modernization Act (FSMA) - High Level Basics

Food Safety Modernization Act (FSMA) - High Level Basics

Attend this webinar to learn the high-level requirements of the FSMA (Food Safety Modernization Act). Rules. Update your crucial knowledge about each of these associated rules including the basic requirements for each of the rules. You will also learn why FSMA is needed and the history of the new legislation and how the new legislation differentiates from the previous.
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
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.
Recognizing and Responding to "Red Flags" in Clinical Operations

Recognizing and Responding to "Red Flags" in Clinical Operations

In this webinar, learn about the several regulatory requirements sponsors need to comply with for the development of the drug product. These requirements expand to include interaction with other regulatory agencies, both Federal and State. The post-marketing obligations encompass more functional areas of the company; including sales and marketing, medical affairs, and external spokespersons.
ISO 13485:2016 - What are the hot topics and changes?

ISO 13485:2016 - What are the hot topics and changes?

In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
Care Coordination: A Fundamental Role for Managing Cost and Length of Stay

Care Coordination: A Fundamental Role for Managing Cost and Length of Stay

In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
Where FDA Is Heading in Regulating Laboratory-Developed Tests

Where FDA Is Heading in Regulating Laboratory-Developed Tests

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
Writing and Revising SOPs for Increased Operational Efficiency

Writing and Revising SOPs for Increased Operational Efficiency

This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
Aseptic Processing Overview and Validation

Aseptic Processing Overview 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.
Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data

Confidence/Reliability & Tolerance Calculations for Extremely Non-Normal Data

Standard methods of statistical analysis of process capabilities require normally distributed data or transformations to normality. When that is impossible, due to data having a bimodal or other distribution, the only practical alternative to calculating a high level of confidence/reliability or an acceptable Tolerance limit is to use Reliability Plotting.

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