ComplianceOnline

A Systematic Approach To Writing Effective Standard Operating Procedures (SOPs)

Instructor: Angela Bazigos
Product ID: 702429
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA compliant SOPs training will explain how to write, organize, and maintain Standard Operating Procedures (SOPs) and train personnel so that you can ensure FDA compliance in a way that is concise, reproducible and easy to follow.

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 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. The course will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. The course instructor will offer guidance on how to get from regulations to the SOP. Finally, best practices for creating, implementing and maintaining SOPs using a risk based approach and best practices for getting SOPs ready for inspection will be presented.

Areas Covered in the Webinar:

  • 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 Will Benefit:

  • CEOs
  • Regulatory VPs
  • Quality VPs
  • IT VPs
  • Regulatory Affairs Professionals
  • Quality Managers
  • Quality Engineers
  • Small Business Owners
  • Consultants
  • Regulators
  • GxP Professionals

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.

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