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ISO 45001: What is Emergency Preparedness and Response?

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

  • What ISO 45001 means by an emergency…
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Added by Adam Fleming on March 10, 2020 at 8:11am — No Comments

ISO 14001: What is Emergency Preparedness and Response?

With any environmental management system (EMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your environmental impact when problems occur.



In the webinar we will look at:

  • What ISO 14001 means by an emergency…
Continue

Added by Adam Fleming on March 10, 2020 at 8:10am — No Comments

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments.

There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

Added by Adam Fleming on March 9, 2020 at 5:53am — No Comments

ISO 45001: What is Emergency Preparedness and Response?

With any occupational health & safety management system (OHSMS) you will have identified potential problems that could occur, and you will need to plan a response so that you can quickly react to these emergencies.

This webinar will discuss these plans in detail so that you can not only meet the requirements of the Iso 14001 standard, but also reduce your OH&S impact when problems occur.



In the webinar we will look at:

  • What ISO 45001 means by an emergency…
Continue

Added by Adam Fleming on March 9, 2020 at 5:52am — No Comments

Supplier Auditing for Medical Device Companies

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.

Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.



You'll learn about the essential elements of…

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Added by Adam Fleming on March 9, 2020 at 5:51am — No Comments

Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…

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Added by Adam Fleming on March 5, 2020 at 6:20am — No Comments

Production and Process Controls for Medical Device Companies

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.

Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…

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Added by Adam Fleming on March 5, 2020 at 6:20am — No Comments

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Added by Adam Fleming on March 5, 2020 at 6:19am — No Comments

3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

Added by Adam Fleming on February 17, 2020 at 6:42am — No Comments

Metrology: Statistical Analysis of Measurement Uncertainty

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…

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Added by Adam Fleming on February 17, 2020 at 6:41am — No Comments

Metrology: Statistical Analysis of Measurement Uncertainty

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…

Continue

Added by Adam Fleming on February 17, 2020 at 6:41am — No Comments

Change Management System

The presentation will focus on FDA responses to failures in Change Management.

The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Added by Adam Fleming on February 17, 2020 at 6:40am — No Comments

Software As a Medical Device (SaMD): New IVDR Document Requirements

Software As a Medical Device (SaMD): New IVDR Document Requirements

IVD medical device companies should ensure that their software enabled medical devices or software as an IVD medical device is compliant to the new software requirements in the IVDR 2022 regulations. This is the only way by which they can avoid stringent actions that follow from non-implementation, which will affect their revenue, as well as their reputation.

 Compliance4All, a leading provider…

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Added by Adam Fleming on February 14, 2020 at 5:56am — No Comments

Process Capability Analysis by means of Confidence Reliability Calculations

Process Capability Analysis by means of Confidence Reliability Calculations

Testing and/or inspections with the intention of concluding whether or not a product or lot is acceptable vis-à-vis design or QC specifications is something that organizations in the manufacturing and development areas perform regularly. Typically, these tests or inspections happens during design verification/validation or during incoming or final QC.

Calculating the product's or lot's…

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Added by Adam Fleming on February 14, 2020 at 5:54am — No Comments

Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management.

Present some common errors when dealing with risk management.

Present the new additions and changes of the new standard.

Added by Adam Fleming on February 6, 2020 at 5:02am — No Comments

Death By CAPA - Does your CAPA Program Need a CAPA?

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.



We'll discuss best…

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Added by Adam Fleming on February 6, 2020 at 5:01am — No Comments

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement…

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Added by Adam Fleming on February 4, 2020 at 5:33am — No Comments

Software As a Medical Device (SaMD) New IVDR Document Requirements

This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions that can result from failed unannounced audits.

This course will ensure that IVD Diagnostic companies will know exactly what documentation needs to be prepared for a 510(k) regulatory filing. They will also know how to ensure…

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Added by Adam Fleming on February 4, 2020 at 5:32am — No Comments

The Dietary Supplement cGMP rule (21 CFR part 111)

FDA regulates both finished dietary supplement products and dietary ingredients.

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.

    That means that these firms are…
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Added by Adam Fleming on January 22, 2020 at 5:50am — No Comments

Pharmaceutical Drug Registration in China

Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.

On the one hand, factors such as incentives, such as market…

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Added by Adam Fleming on October 9, 2019 at 7:29am — No Comments

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