Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are deeply technical in nature, because of which they make heavy reading. Being the product of studiously and meticulously carried out research and finding, these submissions are very scientific and technical. Mastering the art of making legal writing effective and embellishing it is necessary for those who make FDA submissions because this can make these documents lucid and pleasant.

It is the habit of most law schools to prepare future attorneys by teaching them the art of summarizing and sharpening intricate and heavy textual and academic matter into crisp, concise and credible arguments. It is in situations such as drafting responses and applications to FDA that these kinds of writing skills become vital. The FDA expects responses to their queries, or for that matter, any poser that requires a response, to be very exact, scientific and technical. So, developing the art of effective legal writing skills for FDA submissions is a big need for those who prepare legal documentations.

Ridding submission documents of heavy text

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Making submissions about the product apart; effective legal writing skills for FDA submissions need to be developed for another important reason. Companies have to paddle through a muddle of legally heavy, often confusing regulations, which are legally binding requirements that are based upon statutory laws and judicial opinions.

Professionals in the pharmaceutical and medical device companies are required to handle these and respond to these at the appropriate times. A firm grasp of the requirements for doing this is needed for clearly understanding how to frame persuasive arguments and to negotiate with the FDA.

Effective legal writing skills can contribute to success in FDA submissions

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Effective legal writing skills for FDA submissions can stand between the success and failure of many new drugs, biologic or medical device projects, because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities and could become a reason for rejection of the submission.

This is why the more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. All these facts make the cultivation of effective legal writing skills for FDA submissions extremely important.

Major learning on effective legal writing skills for FDA submissions

Effective legal writing skills are essential for FDA submissions

The ways of making legal writing skills effective for FDA submissions will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The Director of this highly important and rewarding session on legal writing skills for FDA submissions is Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com.  In order to get clarity on how to develop the right tools needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting Effective legal writing skills are essential for FDA submissions

Effective legal writing skills for FDA submissions improve the chances of success

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At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success. Good regulatory writing may help to meet FDA branch-level requirements; but effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

The seminar will be highly useful to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. These include Regulatory Affairs professionals, Quality Assurance professionals, Marketing professionals, Scientific and Engineering/Product Development Managers, and Consultants to any regulated industry.

At this webinar, Michalik will cover the following areas:

Get your HIPAA compliance right in six simple steps

The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “… a comprehensive and thorough approach to assessing and addressing the risks to all of the Protected Health Information (PHI) they maintain”.

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Although Risk Analysis is mandatory; HIPAA audits of 2012 showed that as many as four fifths of health care providers failed to comply with this mandatory requirement. Covered Entities and Business Associates are under severe pressure to do a HIPAA Risk Analysis of all the PHI’s they maintain. Most of this, they are expected to do on their own. This explains perhaps just why 80% of health care providers failed to do the Risk Analysis, a fact discovered by the HHS. In fact, the incidence of HIPAA violations has been increasing so steeply that 2015 was sardonically referred to in HIPAA circles as the “Year of the Breach”. This fact leads to the next important point: higher and greater number of government enforcement and private lawsuits.

Learn the ways of getting HIPAA compliance right in just six simple steps

The above facts make it absolutely imperative for Covered Entities and Business Associates to get every aspect of the HIPAA compliance right, in the manner suggested by Jocelyn Samuels. This is precisely what GlobalCompliancePanel, a highly renowned provider of professional trainings for all areas of regulatory compliance, will be imparting at a two-day, in person seminar. To enroll for his event, just visit

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900616SEMINAR?master-HIPAA-compliance-six-steps-San-Diego.

The Director of this highly meaningful and valuable seminar is the well-known expert on HIPAA compliance, Paul Hales. Paul’s credentials get augmented by the fact that he has, with a team of expert advisors and practical field testers, created a method of making all HIPAA regulations accessible to the everyday person. Paul’s method explains all the aspects of HIPAA in uncomplicated and simple language and carries the exact citations to each regulation. This method is directed at organizations’ legal counsel who may not be well versed or experienced in HIPAA, and will be a major part of this seminar.

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Major benefits by learning from the expert

Organizations that are required to carry out HIPAA audits will gain enormously from this seminar. It will help them to save money, time, and research. Paul will discuss how Business Associates and Covered Entities can grow their practice and be compliant. His method will serve as the very foundation on which organization can implement their HIPAA Compliance Program. Most importantly, he will teach how they can grow what is most valuable to their business: Their patients. Paul’s HIPAA compliance method, which consists of six easy steps, will create a level of quality to the advice that the legal counsel provides.

He will take participants of this seminar through a Risk Analysis for their organization and will also delve into the Privacy, Breach, and Security Rules as applicable to their particular organization.

GolbalCompliancePanel will Conduct webinar on “Root Cause Analysis”

Overview: This course provides clarification of the competencies to plan effective, efficient and thorough investigations and design a process for the successful elimination of recurring failures and deviations. 

The material will examine the investigation process from failure identification and notification through documentation,  describe various analysis techniques to help you visualize the problem, and reveal the number one skill, as well as common pitfalls, in reaching correct root cause.  The primary objective of this course is to demonstrate the value of conducting proper root cause analysis as part of your investigation system.  Emphasis is placed on application and how to facilitate root cause analysis.  This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques.

Why you should attend: Inadequate failure investigations continue to be a major GMP deficiency cited within routine and for-cause regulatory inspection reports from both the FDA and EU regulatory agencies. More and more firms continue to operate with an unsuccessful approach to the failure investigation process and, subsequently, do not conduct an efficient or effective root cause analysis.  As a result, in a majority of companies, the common and significant root cause is being improperly reported as human error.  Consequently, the same deviations continue to recur; processes become non-productive due to unidentified equipment malfunctions, along with employee distrust.

Areas Covered in the Session:

  • Phases of an investigation
  • Definition and Principles of Root Cause analysis
  • Skills of an Investigator
  • The Interview
  • Problem Solving
  • Problem Statement
  • Root Cause Analysis Tools
  • Barriers and Controls