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Adam Fleming's Blog – March 2020 Archive (8)

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 8:13am — 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 10, 2020 at 8:12am — 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 5:56am — 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 5:55am — 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 5:54am — 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 6:23am — 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 6:22am — 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 6:21am — No Comments

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