Writing and Enforcing Effective SOPs
Course
In Chicago (USA)
*Indicative price
Original amount in USD:
$ 1,495
Description
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Type
Seminar
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Level
Advanced
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Location
Chicago (USA)
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Class hours
9h
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Duration
2 Days
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,
Important information
Documents
- writing-managing-effective-SOPs-Chicago-IL.pdf
Facilities
Location
Start date
Start date
About this course
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.
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
Reviews
Subjects
- Writing
- Industry
- Writing Skills
- Operating System
- Regulations
- Fda
- Compliance
- Regulation Law
- Risk Complaince
- Risk Mgmt
Teachers and trainers (1)
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Course programme
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 ScheduleLecture 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
Additional information
NetZealous LLC DBA GlobalCompliancePaneljohn.robinson@globalcompliancepanel.com support@globalcompliancepanel.com Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901756SEMINAR?emagister
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Writing and Enforcing Effective SOPs
*Indicative price
Original amount in USD:
$ 1,495