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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