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March 2019 Blog Posts (7)

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…

Continue

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

Try These 3 Things When You Face an FDA Inspection

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.

Yet,…

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Added by Adam Fleming on March 11, 2019 at 8:57am — 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

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