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.
FDA Compliance and Enforcement Trends focused on Data Integrity

FDA Compliance and Enforcement Trends focused on Data Integrity

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.
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.
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).
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.
The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111

The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111

This webinar will evaluate the chief areas of the Dietary Supplements FDA CGMP compliance requirements as required by in 21 CFR 111, the US Law – this and related regulations mandate a ‘total quality system’ -- from customer requirements thru development, production, to customer use/feedback. Labeling requirements will also be discussed, including those uniquely geared to nutraceuticals. The steps resulting in the present FDA regulatory requirements will be reviewed. This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented) for a neutraceutical company.
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.
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.
ISO 14971 Medical Device Risk Management Training

ISO 14971 Medical Device Risk Management Training

This course will give an introduction into the new ISO 14971:2019 and how to create a risk management file according the ISO 14971:2019. It will give you an overview about the requirements the interfaces to Post-Market-Surveillance, Clinical Evaluation, Bench-Testing and Life-Cycle-Management. and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.
How To Manage Supplier Compliance Through Automation

How To Manage Supplier Compliance Through Automation

Learn best practices how to manage suppliers from start to finish. In this webinar, you will learn tips for equipping purchasing teams when they buy raw materials and/or finished goods, how to set up policies around supplier compliance, how to train staff to manage and how to set this all up using automation.
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
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.
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.
FDA Is Here, Now What?

FDA Is Here, Now What?

Attend this webinar how to handle the FDA if they show up at your door or in your email. FDA conducts regular inspections on a daily basis. Learn what rights you do and do not have when they show up for an inspection. Also, learn how to be prepared and what to do when they show up.
How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

How to Ensure Your Foreign Vendors are FDA Compliant: Conducting Vendor Audits, Monitoring, and Using Checklists

This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations, what to do and what not to upon selecting a foreign vendor. It will also provide audit formats and checklists for ensuring a foreign vendor is qualified.
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.
Streamlining your QMS and Audit System for Remote Audits

Streamlining your QMS and Audit System for Remote Audits

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
How to Investigate Environmental Monitoring Excursions

How to Investigate Environmental Monitoring Excursions

This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.

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