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Adam Fleming's Blog (243)

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

Death by CAPA - Does your CAPA Program need a CAPA?

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

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Added by Adam Fleming on February 7, 2020 at 5:54am — No Comments

Death by CAPA - Does your CAPA Program need a CAPA?

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

Continue

Added by Adam Fleming on February 7, 2020 at 5:54am — No Comments

Death by CAPA - Does your CAPA Program need a CAPA?

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

Continue

Added by Adam Fleming on February 7, 2020 at 5:54am — No Comments

Process Capability Analysis by means of Confidence Reliability Calculations

The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

Next, detailed descriptions are given for how to calculate confidence/reliability for data that is either pass/fail (i.e., "attribute" data), normally-distributed measurement data, non-normally distributed measurement data that can be transformed into normality, or non-normally distributed measurement…

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Added by Adam Fleming on February 7, 2020 at 5:52am — No Comments

Save Your Food Business!! - Business Continuity & Disaster Recovery

Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.

Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.



While consumer…

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Added by Adam Fleming on February 7, 2020 at 5:51am — No Comments

Save Your Food Business!! - Business Continuity & Disaster Recovery

Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.

Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.



While consumer…

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Added by Adam Fleming on February 7, 2020 at 5:51am — No Comments

Save Your Food Business!! - Business Continuity & Disaster Recovery

Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.

Failing to maintain consumer safety in the food industry, is extremely costly both in human life and / or suffering and in terms of the costs for recalls, fines levied against the company responsible for the lapse in safety, and impact to the reputation of the company, which can become irrevocable.



While consumer…

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Added by Adam Fleming on February 7, 2020 at 5:51am — 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

Facts about deviation investigations everyone should know

Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.

One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas…

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Added by Adam Fleming on August 12, 2019 at 8:35am — No Comments

FOOD SUPPLY CHAIN – An Incredibly Easy Method That Works For All

A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received a huge boost of late with the emergence of the cloud, which is set to help it overcome one of its biggest stumbling blocks, namely space, the added power of computing, and wider methods of algorithms.

While one would like to…

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Added by Adam Fleming on May 16, 2019 at 7:05am — No Comments

Try These 3 Things When You Face an FDA Inspection

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.

Yet,…

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Added by Adam Fleming on March 11, 2019 at 8:57am — No Comments

INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable…

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Added by Adam Fleming on February 21, 2019 at 7:40am — No Comments

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