Water System Biofilm Control and Microbial Monitoring Myths

Teri C. Soli
Duration: 90 Minutes
Webinar Id: 20263
Instructor: Teri C. Soli

Price Details

Recorded Webinar
$190. One Attendee
$390. Unlimited Attendees

Unlimited Attendees: Any number of participants

Recorded Version: Unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of live webinar)

Overview:

Human error is known to be the primary cause of quality and production losses in many industries.

Human error is known to be the primary cause of quality and production losses in many industries.Although it is unlikely that human error will ever be 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 essential to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are so that procedures can be human engineered, improved and fixed.

Why you should Attend:

Procedures account for more than 40% of human error events in manufacturing. The majority of regulatory citations are also related to procedures. Procedures are essential for both execution and audits.

These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. We will discuss from content development to formats designed for human error reduction due to procedures.

Areas Covered in the Session:

  • SOP writing outline
  • Content development
  • The rationale for procedure use
  • Regulatory compliance background
  • Universal purpose of procedures
  • The Human Perspective
  • Human Error as a root cause
  • The thinking and reading process
  • Common mistakes and causes
  • How to create and maintain a procedure
  • Goals of a procedure
  • Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar 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 Leaders and Managers
  • Plant Engineering
  • Compliance Officers
  • Regulatory Professionals
  • Executive Management
  • Manufacturing Operations Directors
  • Human factors Professionals

Speaker Profile
T.C. Soliis a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. and for the past 16 years has offered troubleshooting consulting and training services covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 42 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Catalytica Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

He has served the past 20 years as a member of USP Expert Committees responsible for everything related to high purity water in USP/NF. He continues to serve USP with his water expertise in the role of Expert Advisor. He is an Approved USP Instructor, and in addition to this Pharmaceutical Water course, has given multiple webinars for Compliance4All as well as the USP Education Department. He previously served for 18 years on the PhRMA Water Quality Committee whose achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection since 1996 (USP 23, Supplement 5) and since adopted world-wide.

Dr. Soli is a recognized global expert consultant, speaker, and trainer in contamination and biofilm control in the Biopharmaceutical, Medical Device, Personal Care Product, and Beverage Industries and has coauthored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.

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