Quality Improvement Through Standard Operating Procedures


Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.  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 Grou........

Overview

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. 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 an explanation of 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.Virtually every FDA the inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.

Why should you attend this webinar?

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 an 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.

Areas Covered in the Session:

  • 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:

Target Audience:
Pharma, Biotech, Medical Device, Anyone involved with FDA

Target Companies:
Pharma e.g. Pfizer, Roche, GSK; Biotech e.g. Genentech; Medical Device e.g. Medtronic, Stryker; CROs e.g. Covance, Quintiles, Theorem etc.



Webinar Id: LSHCAB0012

Training Options:

Duration: 90 mins

 11/18/2019

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$189 (Live)                    $290 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$388 (Live)                    $679 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$776 (Live)                    $1117 (Live + Recorded)

 Recorded: [Six month unlimited access]

$241 (Single Attendee) $499 (Unlimited Attendee)

Refund Policy
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