FDA Audit Checklist Clinical Trials Seminar 2018

FDA Audit Checklist Clinical Trials Seminar 2018
Event on 2018-04-26 09:00:00
Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it. Why you should attend: "Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers. We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings. "Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available. Areas Covered in the Session FDA legal authorityTypes of inspectionsFDA investigator trainingFDA's written procedures, policy and operations guideIndustry inspection protocolWhat to do and not do during an inspectionForm FDA 483 responseWarning Letter responseEnforcement Who Will Benefit: Regulatory AffairsQuality AssuranceManufacturing Agenda: Day 1 Schedule Lecture 1: FDA Inspection authority FDA Inspection authorityInspectional refusal prohibition Lecture 2: Types of Inspections: purpose, scope and scrutiny Comprehensive GMPAbbreviated GMPDistrict or Center DirectedRegulatory Follow-upSurveillanceLimitedFor Cause Lecture 3: Impact on you during and after inspection How to interact with the FDA investigatorWhat not to say and doYour protocolMismanagement of the inspection Lecture 4: FDA Investigator Training – This is what they are thinking On the job training and supervisionTechnical, classroom and mock inspectionsEvidence development to tell the storyPhysical and documentary samples of your violationsWriting reports, inspectional observations and sample documentationPhysical threats and assault Lecture 5: Investigations Operations Manual Procedures and technical guidance. FDA's rules for themselvesFDA organization chart "in the field." Who is watching you? Compliance Programs Section III – the inspection / specific issuesSection V – the regulatory response / risk assessment Lecture 6: Investigations Operations Manual (continued) Writing inspectional observations (Form FDA 483)Writing establishment inspection reportsEvidence documentation and custody Mock "Limited" inspection Day 2 Schedule Lecture 1: FDA Form 483 – List of objectionable conditions, aka list of observations PurposeFormat / organizationManaging 483 observations during the inspectionResponding to 483 observations during "discussion with management" What it meansHow to manage the discussionHow to challenge a 483 observationWhat to say and not say Lecture 2: Your written response to a 483 Understanding the 483 – using an FDA issued 483Time deadlinesStrategy for corrections and corrective actionEvidence of corrections and corrective actionEmpty promises Lecture 3: FDA Warning Letter – advisory of possible legal action FDA Warning Letter proceduresResponding to a Warning Letter – in 15 working days. Group Hypothetical Warning Letter Response – in 10 minutes Lecture 4: FDA Enforcement Actions Judicial SeizureInjunctionProsecutionMonetary penalties Administrative Import / ExportGovernment contractsOther government agency advisoriesFinesPremarket holds Speaker Casper Uldriks ex-FDA Expert and former Associate Center Director of CDRH Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Location: Seattle, WA Date: April 26th & 27th, 2018 and Time: 9:00 AM to 6:00 PM Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Price: Register now and save 0. (Early Bird) Price: ,295.00 (Seminar Fee for One Delegate) Until March 10, Early Bird Price: ,295.00 From March 11 to April 24, Regular Price: ,495.00 Register for 5 attendees Price: ,885.00 ,475.00 You Save: ,590.00 (40%)* Register for 10 attendees Price: ,122.00 ,950.00 You Save: ,828.00 (45%)* Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar At 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- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! NetZealous LLC DBA GlobalCompliancePanel john.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407 Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com Registration Link Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel Early Bird – Seminar Fee for One Delegate – 95.00 Regular Price – 95.00 Register for 5 attendees – 85.00 Register for 10 attendees – 22.00

at Courtyard Seattle Sea-Tac Area
16038 West Valley Highway Tukwila Washington 98188 USA
Seattle, United States

Marketing & Public Relations Dos and Donuts

Marketing & Public Relations Dos and Donuts
Event on 2017-11-02 16:00:00
Join us for a quarterly information session about Denver’s PR, marketing and communications industries. This event is geared toward those who are new to Denver or to the marketing and PR industries, including recent graduates or people making a career change. It's also a great opportunity to connect with people from Blake Communications and Heinrich Marketing.   Please note, this event tends to fill up. If you know you won't be able to make it, please cancel your reservation so someone else may take your place. Thank you! 

at Heinrich Marketing Office
2228 Blake Street, Suite 200
Denver, United States

Masterclass – Communicating Effectively as a Business

Masterclass – Communicating Effectively as a Business
Event on 2017-10-26 09:00:00
Effective communications and marketing play a vital role in any organisation’s performance. Keep ahead of the competition and update your skills in this short, interactive workshop providing participants with a taster and introduction to the key themes and actions involved in effective communication. New for 2017 the masterclass will cover; 1. What is communications / marketing and why should you have a strategy and a plan? Introduction to the benefits of planning. 2. How to build an effective brand identity Building the foundations – mission statement and purpose / values / USP / branding and style and the importance of consistency in everything that you do. Key tools to have eg boilerplates, brand folder. 3. How to make sure you stand out from your competitors Looking at your USP, what makes you different to your competitors? What are your competitors doing well or not so well? What are they saying or not saying that you can take advantage of? 4. How to target your audience Who do you need to communicate with and why? Where do they go? What do they do? What are they interested in? 5. How to write an effective plan Make sure what you do is aligned with your business goals and objectives. Be specific and consistent. Prioritising your actions and your budget. How do you know if it works? Reviewing your actions Workshops run by experts Lucy Rennie – Director at Lucy Rennie Communications Limited We are a strategic communications agency that helps your business to shine through excellent communication. With over 15 years’ experience working in international business, communications and marketing, at Lucy Rennie Communications, we understand the different challenges you face and can speak the same language. We are fiercely passionate about people, communications and public relations and our vision is to provide expertise, know-how and enthusiasm to small and medium sized business owners, managers and teams in an approachable, affordable and flexible way. We strongly believe that everything you do should be in line with your business objectives, values and brand identity, so we work with you to define your bespoke communications strategy with them in mind.

at Harborough Innovation Centre
Wellington Way, Airfield Business Park
Hull, United Kingdom

Bitumen: The people, performance and passions behind Alberta’s oil sands

Bitumen: The people, performance and passions behind Alberta’s oil sands
Event on 2017-09-11 14:00:00
Please join us for the launch of Peter McKenzie-Brown’s comprehensive history of Alberta’s oil sands, which covers the last three centuries.. Peter’s book is the story of the world’s second-largest petroleum resource. The book speculates about oil sand encounters with the oils sands by Indigenous peoples, but the known story begins in 1715, with Hudson’s Bay Company reports. The cover photo shows the Bitumount oil sands plant, which bravely tried to make an oil sands mine profitable during the Great Depression, when an international cartel kept oil prices artificially low. The focus of the author’s remarks will be the development of Canada’s largest petroleum company. To whet your appetite, please read petroleum historian Earle Gray’s foreword by clicking on this link. Don’t forget to whet your appetite at the September 11th book launch, too. Peter’s other books include Footprints: The Evolution of Land Conservation and Reclamation in Alberta (2016, with Robert Bott and Graham Chandler); Barbecues, Booms and Blogs: Fifty Years of Public Relations in Calgary (2008; co-editor and contributor); In Balance: An Account of Alberta’s CA Profession (2000, with Stacy Phillips); The Richness of Discovery: Amoco’s First Fifty Years in Canada (1998); and The Great Oil Age: The Petroleum Industry in Canada (1993, with Gordon Jaremko and David Finch.)

at The Glenbow Museum
130 9 Avenue Southeast
Calgary, Canada

Top Management Team Strategic Plan Upgrade 2-Days Oregon Coast

Top Management Team Strategic Plan Upgrade 2-Days Oregon Coast
Event on 2017-08-28 08:00:00
Top Management Team Strategy Upgrade "However beautiful the strategy, you should occationally look at the results" — Winston Churchill HOW TO DEFEAT THE COMPETITION! WHAT'S IN YOU STRATEGY TOOLBOX? "Without MONEY Forget  About It" — Emerson & Elizabeth Stone  Situation. The current highly competitive business marketplace coupled with the threats of terrorism and natural disasters requires exceptional business savvy.  Mission. Sustained business success requires timely collaborative strategic, tactical, and operational win-win asset allocation and alignment with flawless execution. Balancing multiple competing demands – most especially customer and employee loyalty – within the context of finite resources is the business challenge of the day. Concept. What are the leadership competencies and business capabilities for sustained success in today's challenging business environment? Our Masterpreneurship® Top Management Team Business Strategy Upgrade program squarely addresses this question by providing a best practices, tool-focused approach to sustainable business success. Each two-day program puts all the pieces together: A masterful blend of facilitator presentations, case studies, business analysis, action planning, group exercises, and extensive peer interaction – research-based, comprehensive, cutting-edge. Providing a unified perspective on strategic competitive advantage, innovative marketing, tactical alignment, and operational excellence. Focusing on strategic business decision-making and strategic management team effectiveness, our Masterpreneurship® Top Team Business Strategy Offsite program combines world-class "dantotsu" – best of the best – east-west-business-military strategic thinking with a comprehensive total-team approach to sustained superior business performance to form the world’s leading two-day top management team strategy upgrade program. WORLD-CLASS FACILITATORS Featured Facilitators Our two-day Masterpreneurship® Top Management Team Business Strategy Upgrade program is led by Emerson and Elizabeth Stone, senior partners at Masterpreneurship LLC and leading international business strategy and executive development experts. They each bring over thirty-five years of entrepreneurial and executive leadership expertise from multiple industries and organizations as c-level business, corporate CEOs, board chairs, senior executives, general managers, business consultants and executive coaches:  Helping business owners, CEOs and top strategic management teams from all sizes of business, professional, governmental and not-for-profit organizations, including Fortune 500, multi-nationals, NATO, the U.S. Department of Defense, health care organizations, small high tech start-ups, growing/IPO directed companies, plus individual executives, celebrities and public figures both in the United States and abroad more effectively achieve their personal, professional and organizational objectives.  Offering a unique combination of experience and expertise making them trusted partners to clients globally concerning their most challenging business issues especially with those business executives who are READY TO TAKE THEIR ORGANIZATION TO THE NEXT LEVEL.  About Elizabeth & Emerson Stone Despite the facts that Emerson loves sports, martial arts and is an "Oregon Duck" and Elizabeth's alma mater is NYU and loves theater and ballroom dancing—coupled with their strong political differences, they still find common ground and are enlightening, entertaining, humorous, engaging, and offer the leading-edge in business strategy development and are much sought after “Rock-Solid” team presenters at seminars, keynotes, workshops and retreats worldwide.  Elizabeth Stone was born in Little Rock, Arkansas and had the good fortune of being a Mauney, whose family fortune began as major shareholders of the only diamond mine in North American. Determined to have her own career, she entered the apparel industry in New York City training with Saks Fifth Avenue and specializing in sales and marketing. Her favorite position was as a buyer for 250 stores. Mid-career Elizabeth moved to the hospitality industry and became a success as a restaurateur, catering company, and event center entrepreneur. Her favorite entrepreneurial memory was becoming friends with President Clinton’s mother, Virginia who was a frequent patron at one of Elizabeth’s restaurants.  Emerson Stone III was born in Hollywood, California where his father helped develop Capitol Records into a world entertainment leader. He learned early the importance of innovation backed by sound business practice. He is a Distinguished Military Graduate and Superior Cadet of the University of Oregon, where he received both his Bachelor of Science Degree in Military Science & Management and a Master of Science Degree in Systems Science. Emerson is a combat veteran serving twice in command and in four battle campaigns with the United States Marine Corps. His Ph.D. studies were in Business Administration with research specialization in executive leadership development at Harvard University/Fielding Institute, including executive stress management study with Professor Herbert Benson at Harvard, which led Emerson to the development of the Stress-Strategy Connection. CLIENTS Our business development solutions are trusted by organizations around the world, including: AAA, Advanced Semiconductor Materials-Japan, Aegon N.V., Airlines Reporting Corp. (ARC), Alcoa Inc, Allied Medical Supply Inc., Alloy Surfaces Inc., Anethcdc, ASM America, AWAL IT Services Co , New Car Dealers Association-NCDA British Columbia, Bayer AG, BMW, Boeing, BJC HealthCare, Calista Corporation, Cerebra TRAINING Systems-Canada, Caterpillar, Chevron Corporation, City of San Jose California, Coca-Cola Company, Dartmouth-Hitchcock Medical Center, Daimler-Chrysler, Department of Homeland Security, Detroit Metropolitan Wayne County Airport Authority, Emory University Hospital, European Health Spas, Facility Group Brazil, FCL Logistics , Friedman Corporation, G&D Integrated, GoDaddy.com, Grand Canyon Resort Corporation, Hawaii Employers' Mutual Insurance Co,, HealthSouth, Hitachi Cable Manchester, Inc., Honda Motor Company, Home Depot, Honeywell, Hunter Public Relations, Ingersoll-Rand/TAO, IBM, Institute of Public Administration Saudi Arabia, Jack LaLane Health Clubs, JDS Uniphase Corporation, Linc Group, Los Alamos National Laboratory, Meggit Silicone Products-UK, Mercedes-Bentz, MoneyGram, Nationwide Mutual Insurance Company, Navajo Nation, Neohapsis, Nextel Communications, Nexen Inc. Canada, Nike, Nevada State Bank, Norbest, Inc., NGAS Northrop Grumman Astro Aerospace, Novartis International AG, Peak Health Solutions, Pearson plc, Pelican Energy Consultants, LLC, Providence Health System, Ritz-Carlton, Sakata Seed America, Inc., Solar Turbines Incorporated, Science Applications International Corporation (SAIC), SNF Holding Company-France, Solar Turbines Incorporated, Signum Advisors, Inc., Staples, Situs Holdings, Synergetics USA, Inc., Technigro Pty Ltd Australia, Tenix, LADS, Inc. Australia, Touchstone Behavioral Health, Transamerica Corporation, US Army, US Department of Defense, US Department of Health and Human Services, US Navy (NAVAIR), Valero Energy Corporation, VMware, Walgreens, WCRA, Xerox, and Zions Bancorporation. AGENDA | 2-Day Top Management Team Strategy Upgrade  Times Masterpreneurship® Top Management Team Business Strategy Upgrade program begins each day at 8:00 AM & ends the first day at 5:00 PM & 3:00 PM the second day to accommodate flights. Break at 9:30 AM-10:00 AM Lunch: 12:00 PM-1:00 PM Break at 3:00 PM-3:30 PM  Modules—Masterpreneurship® Top Management Team Business Strategy Upgrade program is presented sequentially in five modules following our proprietary When Money Matters Most® protocol. CERTIFICATE Awarding of the Masterpreneurship® Top Management Team Certificate in Advanced Business Strategy upon successful program completion.    COST Two-Day Program: ,000 USD for up to 10 participants.  Additional Participants: ,000 per person.  Registration includes all training materials and hot buffet lunch each day.  Participants are responsible for their own travel, food, and lodging Terms: Two Payments ,000 USD through Eventbrite Registration to secure the program. ,000 USD – plus any remaining balance for additional participants – due the day of the program by Corporate or Cashier’s Check. ATTIRE Business casual.  BROCHURE Masterpreneurship® Business Strategy MasterClass SCHEDULE Registration with Strategy Upgrade Program Details and Secure Eventbrite Registration Links: Location: The Four Seasons Hotel Las Vegas Strategy Upgrade Las Vegas 22-23 MAR 2017 Strategy Upgrade Las Vegas 19-20 APR 2017 Strategy Upgrade Las Vegas 24-25 MAY 2017 Strategy Upgrade Las Vegas 21-22 JUN 2017 Strategy Upgrade Las Vegas 19-20 JUL 2017 Strategy Upgrade Las Vegas 23-24 AUG 2017 Strategy Upgrade Las Vegas 20-21 SEP 2017 Strategy Upgrade Las Vegas 25-26 OCT 2017 Strategy Upgrade Las Vegas 15-16 NOV 2017 Strategy Upgrade Las Vegas 06-07 DEC 2017 REGISTRANTS TERMS & CONDITIONS By registering for a Masterpreneurship® Business Strategy MasterClass, you acknowledge that you have read, understand and agree to be bound by the REGISTRANTS TERMS & CONDITIONS at the following link:  Masterpreneurship LLC Terms & Conditions HOW MAY WE HELP? About Us | Contact | Strategy MasterClass | Strategy Upgrade | Strategy Coaching | Strategy Consulting ©1972-2017 MASTERPRENEURSHIP LLC. All Rights Reserved. Masterpreneurship® Proprietary Information.

at Coq D’ Or
140 E Walton Pl, The Drake Hotel
Chicago, United States


Event on 2017-08-19 08:30:00
U.S. Cellular associates will share must-have apps, tips for adventure at free Device Workshop

FAIRMONT, W. V.a. (Aug. 1, 2017) – August is American Adventures Month, and outdoor enthusiasts will enjoy going on a walk or a hike, or navigating bodies of water to celebrate. As travelers set out for adventures of all kinds, they should never leave home without their Apple iPhone 7 or Samsung Galaxy S8 smartphones. Not only are these devices important for communication purposes, they also can provide tools to support any outdoor trek.

U.S. Cellular’s friendly, engaged and knowledgeable associates are ready to assist those interested in learning more about ways to maximize smartphone devices to ensure an enjoyable outdoor excursion. U.S. Cellular will host a free Device Workshop at 8:30 a.m. on August 19th at 201 Tygart Mall Loop. The interactive workshop for Fairmont will provide attendees with information on helpful apps for safety and navigation, as well as tips on how to take the best outdoor photos. Individuals do not need to be a U.S. Cellular customer to attend.

“Our devices play an important role when we are headed outdoors to explore,” said Nathan Waddell, U.S. Cellular’s director of sales in the Mid-South. “U.S. Cellular’s high-quality network with national coverage keeps you connected whether you are hiking, biking or boating outdoors. Taking your smartphone along on your next adventure will not only enhance your trip, but also serve as an excellent safety backup should you need it.”

For more information on the event, please call 304-363-7881.

About U.S. Cellular
U.S. Cellular is the fifth-largest full-service wireless carrier in the United States, providing national network coverage and industry-leading innovations designed to elevate the customer experience. The Chicago-based carrier offers coverage where the other carriers don't and a wide range of communication services that enhance consumers' lives, increase the competitiveness of local businesses and improve the efficiency of government operations. U.S. Cellular has the Highest Wireless Network Quality Performance in the North Central Region, according to the J.D. Power 2017 U.S. Wireless Network Quality Performance Study, and 99 percent of customers have access to 4G LTE speeds. To learn more about U.S. Cellular, visit one of its retail stores or uscellular.com. To get the latest news, promos and videos, connect with U.S. Cellular on Facebook.com/uscellular, Twitter.com/uscellular and YouTube.com/uscellularcorp.


For more information, contact:
Melissa Watkins Katie Frey
Public Relations Counsel Communications Manager, U.S. Cellular
Phone: 804-402-5316 Phone: 773-355-3275
Email: melissawatkins@comcast.net Email: katie.frey@uscellular.com

at U.S. Cellular
201 Tygart Mall Loop
Fairmont, United States

PR LAB with Style-Architects

PR LAB with Style-Architects
Event on 2017-08-01 12:00:00
PR. What is it really? We're thrilled to have this opportunity to teach you exactly what public relations really means, especially in this day + age, and how to use it as a powerful tool to grow your business in an organic, thoughtful, wicked smart way. We'll start with the basics – writing a boilerplate + press release, creating a targeted media list, and designing a PR plan tailored to your business. From there, we'll discuss how to creatively craft pitches, how to develop relationships with the media, and how to identify story ideas/news hooks to build brand awareness. Come to class ready to share your business ideas and arm yourself with questions for us and your classroom colleagues. We're so looking forward to an open dialogue and sharing our experiences with you to get your brand the attention it deserves. A light lunch will be served when you arrive. TOOLS YOU WILL TAKE HOME WITH YOU: A press release templateA PR plan outlineA handful of story ideas/pitches for your brand INSTRUCTORS:  STYLE-ARCHITECTS  |  @STYLEARCHITECTS  |  STYLE-ARCHITECTS.COM CHRISTINA SANDOCK Christina caught the creativity bug at a young age. And now, many years later, she has more than 400 pages of published lifestyle editorial work, over 11 years of creative marketing experience and is the 2013 winner of the National Association of Women Business Owners (NAWBO) “Under 40 Woman Business Owner of the Year” award. Christina leads the vision and direction of Style-Architects by igniting passion and inspiration within her team and clients alike. Her pioneer spirit keeps her collaborative team energized and confident. The growth in awareness of her clients' brand and success is deeply rewarding to Christina. This is a true testament of her dedication and loyalty to her clients and their business. LINDSAY DiLORENZO Lindsay DiLorenzo has created a career around connecting people + creating partnerships to tell big + bright stories. She began her career 20 years ago at Rubenstein, a New York City-based strategic communications and media relations firm. Clients included Rockefeller Center, The Whitney Museum, One.org, DonorsChoose.org, and the Tribeca Film Festival, among many others. A New Yorker at heart, but happy to move back to her hometown, Lindsay relocated to Minneapolis where she spent 10 years as Director of PR for Red Stamp. She has landed clients in media outlets such as The New York Times, The Wall Street Journal, The Today Show, O Magazine and InStyle, to name a few. Now a partner at Style-Architects, Lindsay couldn't be more thrilled to find herself surrounded by wicked smart people and incredibly fun clients. Lindsay simply thrives on promoting organizations she believes in and the people behind them.

at LAB Headquarters @ Loring Corners
1624 Harmon Place
Minneapolis, United States