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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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Who Will Benefit:

This Seminar 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

Day 1 Schedule

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Lecture 1:

The SOP end user, required sections and best practices for SOP development

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Lecture 2:

Tips that help and work when you need to create, clear, concise procedures

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Lecture 3:

Improve your writing skills

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Lecture 4:

Development and formatting recommendations: Content and Structure

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Lecture 5:

Reminders that you need to know when you critique your own procedures

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Lecture 6:

FDA and overall global expectations and requirements for SOP development, implementation and enforcement

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Lecture 7:

Create SOPs for the target audience

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Lecture 8:

Provide appropriate level of details and use writing conventions

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Lecture 9:

Have increased confidence in planning and writing your SOPs

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Lecture 10:

Understand the industry standards for procedure writing, including typical components of documents, and using document templates

Day 2 Schedule

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Lecture 1:

Understand the full life cycle of SOPs

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Lecture 2:

Understand how training is integral to document approval

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Lecture 3:

Control, archival and disposal

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Lecture 4:

Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.

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Lecture 5:

Use various tools such as flowcharting to define a logical procedure

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Lecture 6:

Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message

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Lecture 7:

Ensure the document is written for the correct audience

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Lecture 8:

Link SOPs to good documentation practices

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Lecture 9:

Define clear responsibilities, roles and goals for personnel involved in SOP development

 

David R. Dills

Regulatory Affairs & Compliance Consultant, 
 

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Please contact Marilyn Turner: Phone: +1 929 900 1853  Email: marilyn.turner [a] nyeventslist.com for registrations