RAPS pre-approved webinar on "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" from GlobalCompliancePanel
It is an irony of sorts that although companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493 are required by law to have Standard Operating Procedures (SOPs); there is no guidance on how to write, organize and maintain these critical guidance documents.
- Fresno, CA (1888PressRelease) March 27, 2013 - Description:
Because of this, many companies write SOPs in their own interpretative and subjective fashion. Almost invariably, these end up getting written in complex and incomprehensible ways. As a result, compliance becomes a casualty, because the way in which this is written is impossible to comprehend for the others in the organization. Obscurely written documents catch the FDA's attention when they turn up for audit of these documents.
This webinar is intended to give participants an understanding of how to write their SOP's with clarity. It makes them look at ways by which there is clarity, structure and flow in their SOP's, which is after all, a prerequisite for getting FDA approval. This webinar will teach participants ways to write SOP's that are comprehensible, concise and easily reproducible -just what the FDA expects of them.
Ms. Bazigos will cover the following areas during this discussion:
- SOPs and their relation to the regulations
- SOPs as part of the company's regulatory infrastructure
- SOP on SOPs and how to ensure conciseness, consistency and ease of use
- Risk Based approach on SOP Best Practices for creation and maintenance
- Training on SOPs
- Tools for SOP tracking and when is validation required
- What the FDA looks for in SOPs during an inspection
When: March 27, 10:00 AM PDT | 01:00 PM EDT
By whom:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years' experience in the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and conducts classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management.
More recently, Ms. Bazigos was selected to co-author Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia.
Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.
For whom:
The webinar will benefit
- Anyone that creates/maintains SOPs
- VP, Director, Manager of any dept. that writes SOPs or performs training
- QA/QC
- Regulatory Affairs professionals
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanelcom
Phone: 800-447-9407
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