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FDA Effective Regulatory & Quality Submissions 2017

Start Date:
Thursday, 3 August, 2017
End Date:
Friday, 4 August, 2017 6:00pm
Endocrinology, Internal Medicine, Emergency Medicine, Hematology, Business Practice, Health & Nutrition

Course "FDA Legal Writing Skills that Result in Effective Regulatory & Quality Submissions" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Law school prepares attorneys to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. These writing skills are even more critical when drafting responses and applications to FDA that are predicated on arcane scientific and technical arguments.

Because regulations are legally binding requirements predicated upon statutory laws and judicial opinions, it is essential that professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA. The success or failure of many new drugs, biologic or medical device projects hinge on presenting essential information in a persuasive manner.

Do you use these legal drafting skills when preparing quality and regulatory documents?In this seminar, you will learn the legal writing skills and practical techniques that will enhance your chances for success even if some of your test results or other supporting information are somewhat lacking. Remember, good regulatory writing will meet FDA branch-level requirements but the best and most effective submissions can withstand scrutiny at the FDA Division level.

Why you should attend: Most regulatory, quality and R&D professionals rise within an organization due to their scientific and technical understanding of the products in their company's pipeline. However, those professionals who can prepare written and oral arguments that effectively persuade regulatory agencies to agree with their positions are the one who achieve the highest levels of success within the organization.

Lawyers know these writing techniques - do you? Areas Covered in the Session: 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 claimsTips 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 Who Will Benefit: The seminar will be valuable 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.Regulatory Affairs professionalsQuality Assurance professionalsMarketing professionalsScientific and Engineering / Product Development ManagersConsultants to any regulated industry Agenda: Day 1 Schedule Lecture 1:Day 1: Brief Introduction to Seminar TopicsSummary of Day 1 Agenda - Training Objectives, Processes and DeliverablesRegulatory Affairs & Administrative Law: Public Policy & Legal ObjectivesHallmarks of Effective Legal Representation: Serving the Public while Meeting Client NeedsStrategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives - A Practical SummaryDay 2: Legal Writing Skills Development: Best PracticesSummary of Day 2 Agenda - Training Objectives, Processes and DeliverablesLegal Writing in Quality System Development; Policies, SOPs and Reports; Responses to FDA 483 Inspectional ObservationsLegal Writing in Premarket Product Development; Design Control & Quality-by-Design (Q-b-D); Drug & Biologic IND, medical device IDE and FD&C Act § 510(k)Legal Writing in Postmarket Product Development; New Drug Applications, Biologic License Applications, Premarket Approval Applications; Postmarketing Changes (CBE-30, PAS)Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives - A Practical Summary Lecture 2:Step 1 to Persuasive Legal Writing: Understand the Basic PrinciplesIntroduction to Administrative Law & Legal ArgumentationLegal Principles 101 and Applicability to Regulatory ComplianceLegal Writing: Theory and PracticeHow to Address & Resolve Issues in ContentionIRAC - Issues, Rules, Analyses & ConclusionsAgencies are bound by Rules; Learning to Work within FDA Restrictions Lecture 3:Hallmarks of Effective Legal Representation: Serving the Public while Meeting Client NeedsFinding applicable law: Acquiring "Arrows in your Quiver"; Data and decisions that support your legal argument.Statutory law, regulatory requirements, relevant case law, agency rulings, Guidance for Industry, and Industry consensus standards Lecture 4:Strategic & Tactical Approaches toward Satisfying the Law, Agency Policies and Client objectives - A Practical SummaryBreak out Sessions - Applying Legal Writing Principles to Meet Regulatory ObjectivesCase studies assigned to groups;Draft IRAC responses to persuasively address issues SpeakerRobert J Michalik Robert J Michalik, J.D.., RAC, is a Massachusetts regulatory attorney and founder of, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries.Mr.

Michalik has over 25 years' experience working in the biopharmaceutical and medical device industries. Starting with a bachelor's degree in science (biochemistry), Bob has held a wide variety of technical, quality and regulatory positions that literally span the scope of new product development and commercialization activities. For more than 10 years Mr. Michalik was an Adjunct faculty member with Northeastern University (Boston, MA) Master's Program in FDA Regulatory Affairs.

Location: Raleigh, NC Date: August 3rd & 4th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States Price: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until June 20, Early Bird Price: $1,295.00 From June 21 to August 01, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Courtyard Raleigh-Durham Airport 2001 Hospitality Ct,
North Carolina,
United States

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Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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