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Joseph Wilcox's Blog (13)

Foreign Market Entry Techniques for Everyone Else

In today’s globalized world, competition has increased multifold for most businesses. As globalization brings it with both opportunities and challenges, the marketplace has evolved to a point where it is imperative for companies to become global. This is an opportunity they can ignore at their own peril. International sales should become an essential part of an organization’s business plan.

The cost advantages that accrue from producing overseas, the revenue opportunities from foreign…

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Added by Joseph Wilcox on March 29, 2019 at 7:16am — No Comments

How to Improve Your Technology Transfer Process Skills

The successful launch of pharmaceutical products and their processes is directly related to the success of another factor: their transfer. It is only through successful transfer of these processes that the pharmaceutical company can ensure that its products are not only of the highest quality, but also get delivered to the patients and meet the business demands of the company. Expectedly, the execution of this transfer is not very simple and straightforward. It involves the interactions and…

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Added by Joseph Wilcox on March 27, 2019 at 7:09am — No Comments

Effective Ways to Prepare a Standard Operating Procedure (SOP)

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…

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Added by Joseph Wilcox on March 14, 2019 at 8:21am — No Comments

Effective Ways to Prepare a Standard Operating Procedure (SOP)

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…

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Added by Joseph Wilcox on March 12, 2019 at 8:44am — No Comments

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

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

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 5:20am — 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

Webinar from Traininng.com about Good Documentation and Record Keeping Best Practices (FDA & EMA) on January 24

Fremont, CA: Traininng.com, a reputable provider of training courses for professionals for all the areas of regulatory compliance, is organizing a webinar on the topic, “Good Documentation and Record Keeping Best Practices (FDA & EMA)” on January 24, 2019. The speaker at this webinar is Afsaneh Motamed Khorasani, a Medical and scientific Affairs expert and a Senior Scientist. Please visit to enroll for this…

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Added by Joseph Wilcox on January 9, 2019 at 5:00am — No Comments

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Optimize Your Employee Onboarding: Techniques to Improve and Enhance the New Employee Experience at 26468 E Walker Dr, Aurora, Colorado 80016

June 18, 2019 from 1pm to 2pm
OVERVIEWIn this webinar, we will learn the reasons onboarding experience for new hires is important today. We will learn that the terms orientation and onboarding new employees are not interchangeable. We will learn that orientation is in reality just one step in the onboarding process. We will learn that the HR onboarding process begins before the hire is made.WHY SHOULD…See More
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Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

Workplace safety for workers other than your own 2 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Tara safe Mar 1.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

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