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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.
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.
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
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.
covered in the session:
- The SOP
end user, required sections and best practices for SOP development
that help and work when you need to create, clear, concise procedures
your writing skills
and formatting recommendations: Content and Structure
that you need to know when you critique your own procedures
- FDA and
overall global expectations and requirements for SOP development,
implementation and enforcement
SOPs for the target audience
appropriate level of details and use writing conventions
increased confidence in planning and writing your SOPs
the industry standards for procedure writing, including typical components of
documents, and using document templates
the full life cycle of SOPs
how training is integral to document approval
archival and disposal
ways to avoid or reduce risk of regulatory compliance through better writing of
various tools such as flowcharting to define a logical procedure
- Write a
concise, unambiguous SOP for its intended purpose and stay on-point and
the document is written for the correct audience
SOPs to good documentation practices
clear responsibilities, roles and goals for personnel involved in SOP
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:
Inside Job: The Growing Internal Cyber-Threats and How to Protect Against Them
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance/Quality Control
- Marketing & Sales
- Manufacturing and Technical Services
- 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
Instructor Profile :
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience 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 and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.