ComplianceOnline

This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations.

Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise. There is a contentious debate about microbial counts in the pretreatment system and whether investigations should be conducted to find microbials considered part of the “bad bug” list. Profiling microbials in the pretreatment and whether this operation is warranted or not due to the new ISO-22519. How ISO-22519 applies to compendial compliance or not.

Modules will be given on WFI water systems produced by non-distilled means using a variety of purification modules to achieve WFI quality. Depiction of different production options for non-distilled WFI is will offered and analyzed. Additionally there will be an overview module on the Baseline Guide for Water and Steam Systems, the most comprehensive guide on pharmaceutical water and steam systems in existence.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
Examples of modules to be given at the seminar:
  • Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry
  • Comparison of Hot water, Chemical, and Ozone Sanitization for Pharmaceutical Processes
  • Continuous/Electro Deionization (CEDI)
  • Instrumentation, Measurements, Testing of Source, Pretreatment, and Pharmaceutical Waters
  • Lessons Learned from and In-depth FDA Investigation
  • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems
  • OPEX and CAPEX The Actual Cost Pharmaceutical Water Systems
  • PAT (Process Analytical Technology): An FDA and Industry Effort
  • Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities
  • Production of WFI Water Without Distillation - New Changes in the European Pharmacopeia
  • Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
  • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems
  • Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production
  • The Use of Statistical Process Control (SPC) and Exponentially Weighted Process Statistics (EWPS) for PAT in Pharmaceutical Water Systems
  • Understanding and Troubleshooting Pharmaceutical Water Systems
  • Validation of a Pharmaceutical Water System for the 21st Century
  • Water for Injection (WFI): A Changing Paradigm of Production Methods – USP Perspective
  • Water for Pharmaceutical Use / Water Purification Engineering

Learning Objectives:

You will learn and understand the following:

  • Pharmaceutical Water systems
  • The operations of a pharmaceutical water system
  • The basic chemistry involved in water purification
  • The options of choosing properly defined equipment for individual purification steps
  • The issues of microbial monitoring and sampling
  • The value of different sanitization methods used in pharmaceutical water systems
  • The difference of gram-negative and gram-positive bacteria and their influence in biofilm development
  • The configuration of CEDI, EDI, and Ion Exchange is removing ions from the water
  • The usage of microfiltration (MF), ultrafiltration (UF), and nanofiltration (NF)
  • All modules used in pharmaceutical water production from source water to finished product water supplied to production.
  • The different regulatory, pharmacopeial, and international regulatory issues associated with pharmaceutical water.
  • What lessons can be learned from a regulatory audit or investigation.
  • The usage of Statistical Process Control and Exponentially Weighted Process Statistics to monitor and control your water system long before it hits an action or alert limit.
  • The usage and production of non-distilled WFI.

Who will benefit:

    Pharmaceutical, Over-the-Counter, Beauty, Nutraceutical, Biotechnology, and medical device industry professionals in engineering, critical utilities, technical competencies, maintenance, quality control, quality assurance, engineering management, global responsible production personnel.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(9:00 AM - 5:00 PM)
  • 9:00 AM- 9:15 AM Registration Meet & Greet.
  • 9:15 AM- 10:00 AM
    • Instrumentation, Measurements, Testing of Source, Pretreatment, and Pharmaceutical Waters
  • 10:00 AM- 10:30 AM
    • Lessons Learned from an In-depth FDA Investigation
  • 10:30 AM- 10:45 AM COFFEE BREAK
  • 10:45 AM- 11:45 AM
    • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • 11:45 AM- 12:30 PM
    • PAT Vs. Traditional Validation
  • 12:30 PM- 1:30 PM Lunch
  • 1:30 PM- 2:30 PM
    • Understanding and Troubleshooting Pharmaceutical Water Systems
  • 2:30 PM- 3:00 PM
    • Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities
  • 3:00 PM- 3:15 PM COFFEEE BREAK
  • 3:15 PM- 4:00 PM
    • Rouge Monitoring
  • 4:00 PM- 4:45 PM
    • Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
  • 4:45 PM- 5:00 PM
    • Q&A
Day 02(9:00 AM - 5:00 PM)
  • 9:00 AM- 9:15 AM Registration Meet & Greet.
  • 9:15 AM- 10:00 AM
    • Hot water, Chemical, and Ozone Sanitization
  • 10:00 AM- 10:30 AM
    • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems
  • 10:30 AM- 10:45 AM COFFEE BREAK
  • 10:45 AM- 11:45 AM
    • Non-distillation WFI Options
  • 11:45 AM- 12:30 PM
    • Annex 1 and its Comparison to Compendial Mandates
  • 12:30 PM- 1:30 PM Lunch
  • 1:00 PM- 2:15 PM
    • Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems
  • 2:15 PM- 3:00 PM
    • Validation of a Pharmaceutical Water System for the 21st Century
  • 3:00 PM- 3:15 PM COFFEEE BREAK
  • 3:15 PM- 4:00 PM
    • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • 4:00 PM- 4:45 PM
    • Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production
  • 4:45 PM- 5:00 PM
    • Q&A
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Nissan Cohen

Nissan Cohen
Owner, Biopharmaceutical Water Doc

A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.

Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3

Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.

Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone. Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

    Best Sellers
    You Recently Viewed
      Loading