Webinars

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.
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law

Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law

This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.
Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis / management requirements to evaluate the chief areas of an FDA CGMP compliance inspection / audit to locate areas for implementation and improvement in P&PC.
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.
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
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.
Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
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.
21 CFR Part 11 and QMS Software Risk-Based Implementation

21 CFR Part 11 and QMS Software Risk-Based Implementation

CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

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.
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.
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
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.
Medical Device Cybersecurity Risk Management Training

Medical Device Cybersecurity Risk Management Training

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
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.
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.
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.

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