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Adam Fleming's Blog (255)

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…
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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

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.

  • History and Overview
  • Subpart A: General Provisions
  • Subpart B: Electronic…
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Added by Adam Fleming on February 24, 2020 at 7:41am — No Comments

Dietary Supplements CGMPS - 21 CFR 111 Compliance

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.



This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to…

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Added by Adam Fleming on February 24, 2020 at 7:40am — No Comments

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

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Added by Adam Fleming on February 24, 2020 at 7:39am — No Comments

Validation of HPLC/UPLC Methodologies

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

Continue

Added by Adam Fleming on February 24, 2020 at 7:39am — No Comments

Writing Excellent SOPs

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.



This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well…

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Added by Adam Fleming on February 19, 2020 at 6:22am — No Comments

Implementing an Effective CAPA System

CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.

What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.



This webinar highlights the various regulations governing CAPAs, how…

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Added by Adam Fleming on February 19, 2020 at 6:21am — 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 19, 2020 at 6:16am — 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 19, 2020 at 6:15am — 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 19, 2020 at 6:15am — 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 6:44am — 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 6:44am — No Comments

Risk Management - Implementing ISO 14971: 2018

One of the cornerstones of the safety standards such as ISO 14971 is risk management. The principles relating to risk management set out by these standards keep getting updated from time to time. Because of this, it is imperative for organizations that come under the purview of the ISO standards to implement and maintain safety standards that comply with the requirements set out by them.

ISO 14971’s 2019 update will be explained in a lucid manner at a webinar that is being organized…

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Added by Adam Fleming on February 7, 2020 at 5:55am — No Comments

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