Webinars

Assess Impact For Supplier Change Notices

Assess Impact For Supplier Change Notices

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.
Supplier Management with the new Medical Device Regulation EU MDR 745/2017

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.
Quality Agreements and Their Role as Part of a Quality System

Quality Agreements and Their Role as Part of a Quality System

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485  7.3

Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.
Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration

Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration

The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides for extensive databases, clinical requirements, classifications, conformity, and many defined relationships between agencies, member states, and other directives and regulations.

This webinar deconstructs the many parts of this regulation into the elements of lean documents and lean configuration, providing an opportunity to apply these principles as a way to create and maintain flexibility as this and new harmonized standards and regulations emerge.

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

The US FDA, after years of discussing the harmonization of 21 CFR 820, Device CGMPs (QSR), to the ISO 13485, Device QMS, has finally published their QMSR to replace the previous QSR. On February 02, 2024, they published the final rule in the US Federal Register that revises 21 CFR 820 to include ISO 13485:2016 by reference, called the Quality Management System Regulation (QMSR).
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

Drug Labeling and Packaging: Meeting Regulatory Requirements

Drug Labeling and Packaging: Meeting Regulatory Requirements

The webinar, titled "Drug Labeling and Packaging: Meeting Regulatory Requirements," is a comprehensive exploration of the critical nexus between pharmaceutical labeling, packaging, and regulatory mandates. Over the course of 60 minutes, this session will provide participants with a thorough understanding of the pivotal role that accurate and compliant drug labeling and packaging play in ensuring patient safety and meeting global regulatory standards.
FDA's New Software Validation Requirements

FDA's New Software Validation Requirements

CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability & Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.

Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA). The purpose of CPRA was to modify and expand the requirements of the CCPA, thus amending the original act. CPRA is commonly referred to as “CCPA 2.0.”

CPRA ends the ban on providing the CCPA’s consumer privacy rights to a company’s employees. Under CPRA, all employers must respond to requests from employees to access or correct their personal data. Enforcement of CPRA will become effective in July 2023, enabling companies six months to ramp up their efforts to comply with it.

CPRA also extends new protections to consumers residing in California. Those organizations doing business with these consumers are subject, based on defined threshold of operation, to the compliance requirements.

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

How to Achieve Validation Requirements for a Clean Room Manufacturing Environment

Both the U.S. FDA and EU's MDR expect documented risk-based clean room manufacturing environment per ISO 14644-series, ISO 14698-series (and the old FED-STD 209E).
Optimizing Target Weights for Foods and Beverages

Optimizing Target Weights for Foods and Beverages

This training program will elaborate factors affecting the target weight decision and help determine the tolerable risks of under-filling and the costs of over-filling. Attendees will gain an understanding of process stability and process capability concepts and methods for process optimization.
US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).
Cybersecurity - The Latest US FDA  Requirements

Cybersecurity - The Latest US FDA Requirements

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 
Validation Statistics for Non-Statisticians

Validation Statistics for Non-Statisticians

In this program, we will discuss the common statistics tools and techniques used in validation. Through real world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. Discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion of the concept of process capability and using process capability to set acceptance criteria for validation.

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