Webinars

HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enforcement action.
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.
Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

Pharmaceutical Quality Management - Risk Management and Regulatory Compliance, They are Complementary, Not Incompatible

This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
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.
The 6 Most Common Problems in FDA Software Validation and Verification

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
SaaS/Cloud Risk-Based Validation With Time-Saving Templates

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
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.
How FDA trains its investigators to review CAPA and what should you do to prepare

How FDA trains its investigators to review CAPA and what should you do to prepare

This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.
Applied Time Series Analysis in Healthcare

Applied Time Series Analysis in Healthcare

This 3-hour seminar will provide attendees with the theory and application of time series analysis. The main focus will be on autoregressive integrated moving average (ARIMA) techniques. Variations of the ARIMA and other models which operate under non-linear data, non-stationary data, seasonality, and trends will also be examined.

Performing Effective Management Review of the Quality System

Performing Effective Management Review of the Quality System

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.
The FDA Inspection Process: From SOP to 483

The FDA Inspection Process: From SOP to 483

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
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.
ANDA Submission and GDUFA Guidance

ANDA Submission and GDUFA Guidance

An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
21 CFR Part 111 - Specification Requirements

21 CFR Part 111 - Specification Requirements

The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
The Physician Advisor's Role in Case Management

The Physician Advisor's Role in Case Management

This webinar will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.
Universal Hygienic Design for FSMA Compliance-Equipment

Universal Hygienic Design for FSMA Compliance-Equipment

Hygienic Design in food processing is a given, however FDA’s #483 violations continue to reflect organizations clearly lack the necessary requirements to maintain safe environments for food production. This course will outline the basics food facilities should have in place and how to ensure program meets FDA’s expectations.

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