DUBLIN–(BUSINESS WIRE)–The “How
to Write Effective SOPs” conference has been added to ResearchAndMarkets.com’s
offering.
An essential course for ensuring compliance with Regulatory Requirements
which will be of particular relevance for Pharmacovigilance, Regulatory
Affairs, Clinical Research/Operations, GMP, QA and Document Management
Functions.
Course Overview
SOPs play a crucial compliance role with regulations. It is therefore
essential that they are well written and easy to use by the end users.
If SOPs are not followed correctly, the validity of data generated is
compromised, leading to inspection findings and non-compliance issues
which could lead to delays in bringing a drug/device to market.
This SOP course has been specifically designed to help you develop the
skills to write and produce the content of SOPs using a best practice
process, review and implement SOPs and ensure you comply in a regulated
environment.
You will come away with the confidence to use a process to write, update
and implement SOPs which can easily be understood by the end users.
Attend this programme will show you:
- Master the art of writing user-friendly SOPs
- Learn how to prepare the content of SOPs
- Discover how to implement and manage SOPs effectively
- Carry out effective SOP training
-
Ensure your SOPs incorporate appropriate regulatory
requirements
Who Should Attend:
-
All those in pharma, biotechnology, generics, devices and animal
health industries who are involved in preparing, reviewing and/or
managing SOPs -
Ideal as an introduction to preparing, reviewing and implementing SOPs
and may also be helpful to those wanting to ensure they are aware of
best practice -
Particularly those in GXP areas including clinical research,
pharmacovigilance
Agenda
How to write concise and user friendly SOPs
- When are SOPs needed and why?
-
Discuss the difference between having SOPs, policy documents, work
instructions and local guidance
Review the fundamentals of SOPs
- Determine the scope, roles and responsibilities associated with SOPs
- Identify the essential structure of SOPs
- Discussion to share best practice: Review of what makes a good SOP
- Identify who should write, review and authorise SOPs
- Current thinking in writing SOPs and an example of a good SOP
Write concise and user-friendly SOPs
- Translate the flow of operations into the document
-
Write SOPs that are sufficiently detailed, but not restrictive and
limiting - Understand the target audience and account for end user’s needs
- Tips for how to write the content, format, style and presentation
- Defining SOP content using mind mapping and flow charting
SOP implementation and management
- Review and approval processes for SOPs
- Handling updates – when should SOPs be updated and how?
- Distribution, version control
- SOP training
- How to maximise end user compliance
- Exercise: Write an example SOP
Ensuring your SOPs meet regulatory requirements
- What needs to be included for compliance in GMP areas?
- Current regulatory trends
- Identify common SOP deficiencies
- Tips for what auditors and inspectors look for when they review SOPs
For more information about this conference visit https://www.researchandmarkets.com/r/gkwwrq
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceutical
Manufacturing