Writing and Managing Compliance Documents for Success
In this webinar, the speaker will discuss procedures for how to manage compliance documents to ensure that they pass regulatory requirements and that your company passes a regulatory audit. We will further describe how to write clear and readable compliance documents such as Standard Operating Procedures (SOPs), Work Instructions, and reports.
April 30, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 502987
This webinar will describe GxP/GMP requirements for documentation and the purpose of compliance documents.
We will further describe how to write clear and readable compliance documents such as Standard Operating Procedures (SOPs), Work Instructions, and reports. We will present the methodology on how to make SOPs and Work Instructions valuable tools in the operations of regulated industries companies.
We will describe procedures how to manage compliance documents to ensure that they pass regulatory requirements and your company will pass a regulatory audit.
Why should you Attend:
- Understand requirements for documents set forth by GxP/GMP regulations
- Understand purpose of regulatory documents
- Understand differences between processes, procedures, and work instructions
- Learn how to write effective and compliant Standard Operating Procedures (SOPs) and steps to develop them
- Learn how to write effective and compliant Work Instructions
- Learn how to structure and write reports
- Learn how to review and revise documents
- Learn how to create grammatically sound sentences
- Learn tips for clear written communication
- Learn to manage documents in compliance with regulations
- Have increased confidence in writing and revising documents
Compliance documents are critical for regulatory compliance and for effective business operations. It is imperative that everyone tasked with creating and managing these documents have knowledge of how to create effective documents and how to manage them in compliance with GxP/GMP requirements. development, manufacturing, and testing activities.
Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. Many regulatory citations are also related to Standard Operating Procedures (SOPs). Auditors pay particular attention to documentation to make sure that it complies with GMP and GDocP.
This is so important that if an external audit identifies deficiencies in the documents, the entire organization can be shut down.
This webinar will describe how to write effective and complaint Standard Operating Procedures (SOPs), Work Instructions, and reports.We will also provide tips for clear and sound grammar.
You will also learn how to manage all compliance documents in full compliance with GxP/GMP regulations and be able to pass quality audit.
Areas Covered in the Session:
Who Will Benefit:
- GxP/GMP Requirements for Documentation
- Purpose of compliance documents
- Writing effective and compliant Standard Operating Procedures (SOPs)
- Writing effective and compliant Work Instructions
- Structuring and writing reports
- Review and revise documents
- Rules for clear written documents
- Managing documents in compliance with regulations
- Quality Assurance
- Documentation Managers
- Records Managers
- Document Control
- Medical Affairs
- IT Professionals
- Data Managers
- Safety Managers
- Regulatory Affairs
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management.
Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.
She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users' requirements.
She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.