Effective legal writing skills are essential for FDA submissions

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

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

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

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

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:

• Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations
• Step-by-step analysis of how to present both good and poor data in a persuasive manner
• How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?
• Tips and secrets to framing an argument that makes even poor data look good
• Examples of good writing that can be useful templates for training and skills development
• What you should never say in a quality or regulatory document.

Writing and implementing effective SOP’s

Utmost thoroughness and diligence need to go into writing and implementing effective SOP’s. This is because Standard Operating Procedures are to be designed keeping the exact and fullest details of the task that is to be described. It is a very detailed art as it has to take everything into consideration and leave nothing to chance.

Even the smallest errors or discrepancies or divergences can lead to problems with the product usage. In the context of a laboratory, even with all the details that are standard; details pertaining to the exact situation of the laboratory need to be described. An SOP for even a standardized method such as ASTM or IP can be written insufficiently.

Writing is just one part of the job

If writing an SOP is one job; implementing it is another. Maintaining and assessing are yet other parts of the job. And then, there is the task of revising the SOP if needed. All these are related jobs, but are independent of each other and require different sets of people with their own qualifications and experience to handle.

The need for writing SOPs effectively is best understood in light of the fact that a poorly written and enforced one is among the most common cases of noncompliance that auditors detect.

A seminar on getting writing of SOPs right

The ways of implementing the correct means of writing SOPs for a laboratory will be taught at a seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The seminar will have John C. Fetzer, who is Founder and Principal Consultant, Fetzpahs Consulting, as Director. John brings over 30 years of experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography and has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

To gain clear understanding of how to write SOPs that are effective in both helping those working in the laboratory understand how to put it to effective use and are capable of passing compliance requirements, please enroll for this seminar by visiting Writing and implementing effective SOP’s. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Description of all the steps

At this seminar, John will describe the complex, but necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP. Recordkeeping, safety and training are some of these steps.

John will also describe the reasons for which even standardized methods get insufficiently written. He will explain the steps needed to convert a standard method into an SOP. Laboratory workers, supervisors, managers of a laboratory seeking or under GLP or ISO 17025, and other involved in SOPs, such as Research Associates, Lab Chemists, Lab Supervisors and Quality Officers will derive high value from this seminar.

Over the two days of this seminar, John will cover the following areas:

o  What is the intention and role of SOPs? What tasks require SOPs? The network of SOPs within the Lab

o  What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)

o  Interplay within the lab to improve the draft SOP Iterations?

o  Implementation of the SOP

o  Monitoring and Assessing the SOP. When should an SOP be revised? Revising the SOP.

o  Archiving and documentation. Which SOP to use when? Other requirements.