How to Write Error Free and FDA Compliant Procedures

Speaker

Instructor: Ginette M Collazo
Product ID: 704122

Location
  • Duration: 90 Min
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
RECORDED TRAINING
Last Recorded Date: Sep-2015

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is really important to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are, so procedures can be human engineered, improved and/or fixed.

This webinar will discuss practical approaches to address writing rules to reduce the likelihood of procedures.

Learning Objectives:

  • Understand the importance of procedures
  • Learn why people refuse to use procedures
  • Understand the common human errors and deviations related to the use of procedures
  • Understand the reading and writing processes and how people may impact the processes

Areas Covered in the Webinar:

  1. SOP Writing Outline
  2. Content
  3. The Reason of Procedures
    • Regulatory compliance background
    • Universal purpose of procedures
  4. The Human Perspective
    • Human error as a root cause
    • The thinking and reading process
    • Common mistakes and causes
  5. How to Create and Maintain a Procedure
    • Goals of a procedure
    • Good procedure writing practices (terminology, formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of precautions, warnings and cautions)
    • Procedure styles
    • Use of electronic information networks for procedure access

Who Will Benefit:

  • QA/QC directors and managers
  • Process improvement/excellence professionals
  • Training directors and managers
  • Plant engineering
  • Compliance officers
  • Regulatory professionals
  • Executive management
  • Manufacturing operations directors
  • Human factors professionals

Instructor Profile:

Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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