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Joseph Wilcox's Blog (16)

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

Dealing with OCD in the Office

 

If you have a colleague who gets down to hairsplitting detail at every work she undertakes, to the extent that she takes half a day to complete a task that can be done in half an hour, you have a person with OCD in your midst. Obsessive Compulsive Disorder is a psychological condition in which the person with it is too obsessed with perfection. This penchant for perfection in everything they do can be painstaking for others who interact with them, but for those with…

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Added by Joseph Wilcox on March 7, 2019 at 6:54am — No Comments

Implementing an Effective Succession Plan

Fortune 500 companies and small family businesses alike share a business need - insuring that they have the talent necessary to effectively lead their organizations in the future. One of the most significant contributions a leader can make is insuring his/her business'continuity and sustainability - by having employees who are willing and capable of filling each key position with a plan for doing so when the need arises.

Succession Planning is a:

  • Deliberate, systematic…
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Added by Joseph Wilcox on March 5, 2019 at 7:00am — 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 5:21am — 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

Active Substances and Excipients for Medicines - Rules and Requirements

Quality Assurance, Quality Systems, quality risk management and Quality Control are the cornerstones of Good Manufacturing Practices (GMP). Being a globally acclaimed provider of training courses for professionals, Traininng.com introduces these concepts at this online regulatory compliance training webinar.

The expert, Dr Madeleine S. Fairweather, will present these concepts in accordance with EU GMP Part II. However,…

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Added by Joseph Wilcox on January 18, 2019 at 7:29am — No Comments

Dramatic changes expected into medical device regulations

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.

Nature of…

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Added by Joseph Wilcox on November 22, 2018 at 6:37am — No Comments

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