Seminar Brochure

2-day In-person Seminar:Net ZealousAbout GlobalCompliancePanel:GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-e f f e c t i v e w h i l e b e i n g c o n v e n i e n t . GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. Profess iona ls who undergo t ra in ings f rom GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowBy Regulatory Affairs & Compliance ConsultantDavid Dills,Location: November 21-22, 2013 | Baltimore, MDThe A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)About Speaker:Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Day 1 Day 2Lecture 1: The SOP end user, required sections and best practices for SOP development Lecture 2: Tips that help and work when you need to create, clear, concise procedures Lecture 3: Improve your writing skills Lecture 4: Development and formatting recommendations: Content and StructureLecture 5: Reminders that you need to know when you critique your own procedures Lecture 6: FDA and overall global expectations and requirements for SOP development, implementation and enforcement Lecture 7: Create SOPs for the target audience Lecture 8: Provide appropriate level of details and use writing conventions Lecture 9: Have increased con?dence in planning and writing your SOPs Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates Course Outline:David DillsRegulatory Affairs & Compliance Consultant Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. Overview:Lecture 1: Understand the full life cycle of SOPs Lecture 2: Understand how training is integral to document approval Lecture 3: Control, archival and disposal Lecture 4: Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.Lecture 5: Use various tools such as ?owcharting to de?ne a logical procedure Lecture 6: Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message Lecture 7: Ensure the document is written for the correct audience Lecture 8: Link SOPs to good documentation practices Lecture 9: De?ne clear responsibilities, roles and goals for personnel involved in SOP development 1. Learning Objectives2. Participation certificates3. Interactive sessions with the US expert4. Post event email assistance to your queries.5. Special price on future purchase of web based trainings.6. Special price on future consulting or expertise services.7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen.9. Networking with industry's top notch professionalsProfessionals who will benefit: ? Regulatory Affairs? Clinical Affairs? Quality Assurance/Quality Control ? Compliance? Marketing & Sales? Manufacturing and Technical Services? Engineering? IT/MIS? Executive Management? Laboratory Operations? Customer ServicePrice for One Delegate pass Price: $1,295.00**Please note the registration will be closed 2days (48 Hours) prior to the date of the seminar.Payment Options:? Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link? Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA? PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884 ? Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer informationContact Information:Event CoordinatorToll free: 1800 447 9407 Fax: 302 288 6884Email: support@globalcompliancepanel.comNetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAKindly get in touch with us for any help or information.Look forward to meeting you at the seminarTeam GlobalCompliancePanelRegister now and save $200. (Early Bird)Until September 25, Early Bird Price: $1,295.00From September 26 to November 19, Regular Price: $1,495.00 November 21-22, 2013 | Baltimore, MDwww.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Registration :FormPlease use this form to register online, using your American Express, Visa or MasterCard.To get discounts on group attendance, please call us on1800 425 9409Call us on 1800 447 9407 or fax your PO to 302 288 6884Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include 100 8425 9409 support@globalcompliancepanel.comattendee and payment details in it and fax it to 302 288 6884Terms and ConditionsYour registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clari?cations or doubts on this issue.Cancellations and SubstitutionsIf you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period.A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this.You are allowed to make substitutions at any time till the start of the event. The substituting person should be present well in time for the event with proper written communication and company identity.If registering on the date of the seminar, please make sure you pay for the event using your credit card or check just before the start of the event. To such attendees, we may not be able to give the conference materials on the spot. In such an event; we will send the same after the conclusion of the seminar.No-shows will not be reimbursed.If GlobalCompliancePanel cancels an event, we will not be reimbursing any airfare, accommodation, other costs or losses that the registrants may have incurred. GlobalCompliancePanel reserves the right to change topics and speakers without notice.Seminar Topic:......................................................................................................................................................Date:.....................................................................................................................................................................Attendee 1 : Name ............................................... Title ..................................................... Email ..................................................Attendee 2 : Name ............................................... Title ..................................................... Email ..................................................Attendee 3 : Name ............................................... Title ..................................................... Email .................................................. Attendee 4 : Name ............................................... Title ..................................................... Email ..................................................Company InformationOrganization .......................................................................................Address ..............................................................................................City ........................................ State ........................ Zip....................Country ..............................................................................................Phone ........................................... Fax .............................................Payment Options Check enclosed, payable in U.S. funds to NetZealous LLC, DBA GlobalCompliancePanel Charge to: Visa MasterCard American ExpressCredit card no. ............................................................................Expiration date ............................................................................Total amount $ ............................................................................Signature ....................................................................................(Signature required on credit card and bill-me orders.)Print name .................................................................................. Bill me/my company $ ............................................................Purchase order # ........................................................................(Payment is required by the date of the conference.)Please ?ll this form with attendee details and payment details and fax it to 302 288 6884NetZealous LLC, DBA GlobalCompliancePanel161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USAPhone: 1800 425 9409Toll free (US): 1800 425 9409 / Fax (US): 302 288 6884