2-day In-person Seminar on “The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures)” at Baltimore, MD

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.

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Course Agenda:
Day 1:
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 2:
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 Profile:
David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; 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.

21 Nov - 22 Nov 2013

Baltimore, MD
United States of America
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