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February 2019 Blog Posts (11)

Why and How Do We Fail an FDA Inspection?

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a 60-minute webinar on the topic, “Why & How do we Fail an FDA Inspection”. Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this session. Please visit…

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Added by Joseph Wilcox on February 27, 2019 at 4:48am — No Comments

The New EU Medical Device Regulation

Traininng.com, a well-known provider of professional training for all the areas of regulatory compliance, will organize a 60-minute webinar on the topic, “The New EU Medical Device Regulation”, on February 21. Dr. Salma Michor, who is the founder and CEO of Michor Consulting Schweiz GmbH, who teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission, will be the speaker at this valuable…

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Added by Joseph Wilcox on February 25, 2019 at 6:49am — 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

HPLC Analytical Method Development and Validation

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will organize a webinar on the topic of HPLC Analytical Method Development and Validation, on February 21. John Fetzer, a senior professional in HPLC methods, will be the speaker at this session.

Please visit http://bit.ly/2SEmev3 to enroll for this webinar and gain insights into the core aspects of how to carry out…

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Added by Joseph Wilcox on February 21, 2019 at 6:14am — No Comments

Aseptic Processing Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.

This course will also review…

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Added by Joseph Wilcox on February 20, 2019 at 6:33am — No Comments

Trial Registration and Results Reporting on ClinicalTrials.gov

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).

The Final Rule has been in effect since January 18, 2017. The…

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Added by Adam Fleming on February 18, 2019 at 6:22am — No Comments

An Introductory overview of the FDA and EMA Requirements

The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.

Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new…

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Added by Joseph Wilcox on February 18, 2019 at 5:21am — No Comments

What do Your Customers Really Think About Your Complaint Handling?

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

Please visit http://bit.ly/2GFGiXr to enroll for this webinar.

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A complaint says a lot about a product. It helps the…

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Added by Adam Fleming on February 15, 2019 at 6:54am — No Comments

Using Analytics to Plan Internal Quality Management System Audits

Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are…

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Added by Joseph Wilcox on February 13, 2019 at 6:13am — No Comments

Understanding what Tax Evasion and Tax Fraud mean when monitoring BSA and filing SARs

Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.

Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit…

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Added by Joseph Wilcox on February 6, 2019 at 6:33am — No Comments

Rolling Forecasts: The New Way to Budget

Traininng.com, a reliable provider of professional training for the areas of regulatory compliance, will organize a webinar on the topic, “Rolling Forecasts: The New Way to Budget”, on February 11. The speaker at this 75-minute session is Carl Young, a senior finance and business professional.

Please visit…

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Added by Joseph Wilcox on February 4, 2019 at 5:58am — No Comments

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