Netzealous -MentorHealth, Philadelphia, PA
May 12th & 13th, 2016
Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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 "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. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured. The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. Following SOPs are much more important than writing them. Even the best written SOPs are useless if they are not followed. SOPs are therefore the most popular documents audited by FDA and other Agencies, and certainly your auditors and customers. This session will provide insightful and useful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOPs. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs play in achieving the required level of compliance and quality. Who Will Benefit: This webinar will provide valuable assistance and guidance to pharmaceutical, medical device and biotechnology manufacturers and other firms in the life sciences industry who require a refresher session on writing and enforcing their own SOPs and internal procedures or for those new to this area who desire to gain a better understanding of the SOP process. The employees who will benefit include basically anyone and everyone at your organization who are required to write and/or comply with SOPs, including all levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP process from start to finish, including: · Regulatory Affairs · Clinical Affairs · Quality Assurance/Quality Control · Compliance · Marketing & Sales · Manufacturing and Technical Services · Engineering · IT/MIS · Executive Management · Laboratory Operations · Customer Service · Clinical Research managers and personnel · Specialists/SMEs in all departments · QA/RA managers and personnel · Quality System auditors · Distributors/Authorized Representatives · Legal Counsel · Consultants Agenda: Day One Lecture 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 Structure Lecture 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 confidence in planning and writing your SOPs Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates Day Two 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 flowcharting to define 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: Define clear responsibilities, roles and goals for personnel involved in SOP development Speaker: David R. Dills, 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. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus. Location: Philadelphia, PA Date: May 12th & 13th, 2016 and Time: 9:00 AM to 6:00 PM Venue: Hilton Garden Inn Philadelphia Center City Address : 1100 Arch Street, Philadelphia, Pennsylvania, 19107, USA Price Details: (Seminar Fee for One Delegate - Without stay)-Price: $1,495.00 (Seminar Fee for One Delegate - With stay)-Price: $1,895.00 Quick Contact: NetZealous DBA as MentorHealth Phone: 1-800-385-1607 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/ Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200065SEMINAR Follows us: Twitter: https://twitter.com/MentorHealth1 LinkedIn: https://www.linkedin.com/company/mentorhealth
|