Pharmaceutical Water Systems and Validation: 2018 BioFilm Course

Start Date : April 19, 2018
End Date : April 20, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA

Website

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Course “The A to Z’s of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Overview:

 

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn’t recur.

 

Why you should attend:

 

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

 

Who will benefit:

 

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

 

Agenda:

 

Day 1 Schedule

 

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

Lecture 3:

Water System Validation by Logic Instead of Tradition

Lecture 4:

Implementing Changes to a Validated System

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

 

Day 2 Schedule

 

Lecture 6:

Understanding and Controlling Endotoxin

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

Lecture 9:

Water System Investigation “How-To’s” and Example Case Studies

Lecture 10:

What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues

 

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 39 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

He is in his 18th year on USP Expert Committees responsible for Pharmaceutical Water and has co-authored everything related to water in USP, including their informational chapter Water for Pharmaceutical Purposes. 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 and adopted world-wide.

Dr. Soli is a recognized global expert in contamination and biofilm control in the Biopharmaceutical, Medical Device, and Personal Care Product Industries and has authored 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.

 

Location:  Washington DCDate: April 19th & 20th, 2018and Time: 9:00 AM to 6:00 PM

Venue:  Courtyard Arlington Crystal City/Reagan National Airport   2899 Jefferson Davis Highway Arlington, VA 22202 USA

 

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until March 10, Early Bird Price: $1,295.00 From March 11 to April 17, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees   Price: $7,122.00   $12,950.00 You Save: $5,828.00 (45%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901639SEMINAR?SEO

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Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


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