Download - Writing and enforcing effective so ps
Writing and Enforcing Effective SOPs- Online Compliance Panel
Description:
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.
Objectives of the Presentation:
The SOP end user, required sections and best practices for SOP development
Tips that help and work when you need to create, clear, concise procedures
Improve your writing skills
Development and formatting recommendations: Content and Structure
Reminders that you need to know when you critique your own procedures
FDA and overall global expectations and requirements for SOP development, implementation and
enforcement
Create SOPs for the target audience
Provide appropriate level of details and use writing conventions
Have increased confidence in planning and writing your SOPs
Understand the industry standards for procedure writing, including typical components of documents,
and using document templates
Understand the full life cycle of SOPs
Understand how training is integral to document approval
Control, archival and disposal
Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures
Use various tools such as flowcharting to define a logical procedure
Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
Ensure the document is written for the correct audience
Link SOPs to good documentation practices
Define clear responsibilities, roles and goals for personnel involved in SOP development
Who can 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
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