All Blog Posts (1,642)

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…

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.

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.

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…

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.

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…

Regular (unencrypted) Email and Text Messaging are effective engagement and communication tools that patients like and have the right to use.

A simple 3 step HIPAA safeguard fully protects Covered Entities from violating both HIPAA and the TCPA (Telephone Consumer Protection Act) and stymies expensive TCPA class actions. Unfortunately few take advantage of the 3 step safeguard. And the Internet is awash with mis-information that can get Covered Entities into serious…

One of the most essential ingredients for employee performance, and with it, organizational success, is employee psychology. Employees that have the right frame of mind, the positive one, are the ones who succeed.

Understanding employee psychology helps organizations understand the reasons for which employees behave the way they do at the workplace, the reasons for which they react or respond to certain given situations, the factors that play in their mind when confronted with both…

Healthcare professionals endure enormous stress in the course of their daily work. Being constant witness to pain and suffering is surely the most serious downside of this highly respected profession. Apart from having to see these as part of their routine, healthcare professionals are under pressure from another quarter: that of being professional at their work to the extent that they fulfill the organization’s ROI expectations.

Having to balance the pain of having to see suffering…

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…

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…

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…

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…

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…

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…

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…

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…

Power Query is a somewhat new feature, it first made its entrance in Excel 2010, and now is a standard part of Excel 2016 and 2019.

Power Query is a tool designed for Excel to handle repetitious steps specifically tied to data prep. We all know the drudgery of removing columns, shifting rows, correcting data formats all before we can actually do the work with the data!

The old alternative was to use macros for this redundant work; but even those were hard to edit and not…

Managers and Supervisors are taken to task everyday in managing their Non represented employees. It is important for them to learn the Initial warning signs of Union Organizing long before a Union gets the appropriate number of signed Authorization Cards and the NLRB Conducts a secret Election. Learn here the best Election is the one that is never held .

This course will delve into the 20 +  Initial Warning Signs of Union Organizing, What you Can Do and What you Cannot Do, Guidelines…

Managers and Supervisors are taken to task everyday in managing their Non represented employees. It is important for them to learn the Initial warning signs of Union Organizing long before a Union gets the appropriate number of signed Authorization Cards and the NLRB Conducts a secret Election. Learn here the best Election is the one that is never held .

This course will delve into the 20 +  Initial Warning Signs of Union Organizing, What you Can Do and What you Cannot Do, Guidelines…