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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

Email, Texting & HIPAA-TCPA Compliance - Electronic Message Rules & Myths

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…

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Added by John Robinson on February 12, 2020 at 5:17am — No Comments

The Psychology of an Employee

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…

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Added by kate smith on February 12, 2020 at 5:14am — No Comments

Burning up while Burning out – Compassion Fatigue Awareness & Burnout Prevention for Practitioners

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…

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Added by Roger Steven on February 12, 2020 at 5:10am — 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…

Continue

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

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