The A to Z's of Writing and Enforcing Effective SOPs

Transcription

1 Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: The A to Z's of Writing and Enforcing Effective SOPs Los Angeles, CA July 28th & 29th, :00 AM to 6:00 PM Price (Without Stay) Price: $1, (Seminar for One Delegate) (With Stay) Price: $1, (Seminar for One Delegate) Register now and save $200. (Early Bird) David R Dills Regulatory Affairs & Compliance Consultant, David R. Dills, Regulatory & Compliance Consultant **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. 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, Seminar Pricing Includes (With Stay) 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. Overview 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 Google Nexus 7 Tablet 2 Days Stay Pick-up and Drop Facility (Nearest Airport) Break-Fast and Lunch High Tea Pack of 3 Webinars will be provided which has been done in the past on similar subject

2 Global CompliancePanel 2-day In-person Seminar: The A to Z's of Writing and Enforcing Effective SOPs Agenda: Day One Day Two Lecture 1 : The SOP end user, required sections and best Lecture 1 : Understand the full life cycle of SOPs practices for SOP development Lecture 2 : Tips that help and work when you need to create, clear, concise procedures Lecture 2 : Understand how training is integral to document approval Lecture 3 : Improve your writing skills Lecture 3 : Control, archival and disposal Lecture 4 : Development and formatting recommendations: Content and Structure Lecture 4 : Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures. Lecture 5 : Reminders that you need to know when you critique your own procedures Lecture 5 : Use various tools such as flowcharting to define a logical procedure Lecture 6 : FDA and overall global expectations and requirements for SOP development, implementation and enforcement Lecture 7 : Create SOPs for the target audience Lecture 6 : Write a concise, unambiguous SOP for its intended purpose and stay on-point and onmessage Lecture 8 : Provide appropriate level of details and use writing conventions Lecture 7 : Ensure the document is written for the correct audience Lecture 9 : Have increased confidence in planning and Lecture 8 : Link SOPs to good documentation practices writing your SOPs Lecture 10: Understand the industry standards for procedure writing, including typical Lecture 9 : Define clear responsibilities, roles and goals for personnel involved in SOP development components of documents, and using document templates

3 Global CompliancePanel 2-day In-person Seminar: The A to Z's of Writing and Enforcing Effective SOPs Group Participation What You will get 10% 2 Attendees to get offer 1 Learning Objectives 20% 3 to 6 Attendees to get offer 2 Participation certificates 25% 7 to 10 Attendees to get offer 3 Interactive sessions with the US expert 30% 10+ Attendees to get offer 4 Post event assistance to your queries. Payment Option 5 Special price on future purchase of web based trainings. 1 2 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 6 7 Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. 3 PO: Please drop an to support@globalcompliancepanel.com or call the our toll free for the invoice and 8 Seminar Kit includes presentation handout, ID card, brochure, trainings catalog, notepad you may fax the PO to and pen. 4 Wire Transfer: Please drop an to support@globalcompliancepanel.com or call our toll free for the wire transfer 9 Networking with industry's top notch professionals information Contact Information: Event Coordinator NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: Fax: Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel support@globalcompliancepanel.com