Writing Effective SOP’s

Duration: 90 Minutes
Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues. This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
SOP validation
Instructor: Angela Bazigos
Product ID: 500169
It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Why Should you Attend:
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during a FDA audit.

This webinar will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Objectives of the Presentation:
  • 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
Who can Benefit:
  • CEO
  • Regulatory VP
  • Quality VPs
  • IT VPs
  • Regulatory Affairs professionals
  • Quality Managers
  • Quality Engineers
  • Small business owners
  • GxP
  • Consultants
Live Session - How it works
  • We will send Username and password 24 hours prior to webinar at your email address.
  • Webinar presentation handouts will be shared in pdf format, a day before live presentation.
  • Use the login details to participate in sessions.
  • Clear out your queries through interactive Q&A chat boxes with the speaker.
  • We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
  • Get certification of attendance.
Recorded Session - How it works
  • Once you purchase a webinar you will receive username and password at your email address.
  • Use the login details to view recorded webinars.
  • Presentation handouts will also be shared in pdf format.
  • Access to the recording is valid only till 6 months starting from the date of purchase.
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
Book This Course
  $500.00 Training CD
Free shipment within 4 Days, from the date of webinar completion. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
Do you want to Host
this webinar at your Organization!
Call us at +1-510-857-5896
Email us at webinar@onlinecompliancepanel.com
Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
View More