Water System Validation in Pharmaceuticals Industry 2017

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 should you 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:

·         Microbiology Laboratory supervisors and analysts responsible for water sampling and testing

·         Quality Assurance personnel responsible for water system deviation management and change control

·         Regulatory and Compliance professionals responsible for FDA interactions

·         Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation

·         Facility Engineers responsible for water system design or renovation

·         Validation personnel for water system qualification

·         Change Control personnel involved in water system changes and repairs

·         Production Managers involved with water system use for manufacturing and cleaning

·         Laboratory Managers and Supervisors responsible for lab water systems and other water sources

Agenda:

Day One

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

·         Understand biofilm basics and how it develops

·         Understand the impact of biofilm on the commonly used purification unit operations

·         Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development

·         Understand the how, where, and why of microbial monitoring, action levels, etc.

·         Debunk a few water system myths

·         Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

·         Material and construction limitations

·         Continuous vs intermittent sanitization

·         The importance of biofilm removal

·         How sanitants work (or don't work)

·         When to sanitize

·         Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

·         Why validate a water system?

·         Basic ground rules for water systems before you validate them

·         Micro Test Method "validation"

·         Minimum validation expectations

·         How to figure out what you should validate

·         What happens after the honeymoon is over

·         Is validation ever really over?

·         Special considerations for lab water systems

·         Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

·         Purpose of a Change Control program - a help, not a hindrance

·         When is a change major vs minor, requiring full vs limited re-qualification?

·         What about water use during re-qualifications?

·         FDA validation expectations

·         Reliance on logic and common sense and the disservice of precedent and paradigms

·         Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

·         What are excursions?

·         Water system dilemma: process control or quality control (utility or raw material), or both

·         Intended roles of Alert/Action Levels and Specifications

·         Investigation, necessary and often fruitless

·         Excursion responses and impact

·         Criticality of valves, hoses, & outlet flushing

·         Diagnosing the source of the problem

·         Minimizing unnecessary excursion responses through best practices

Day Two

Lecture 6:

Understanding and Controlling Endotoxin

·         Where does endotoxin come from?

·         What are the properties of endotoxin?

·         How do you get rid of it?

·         How do you detect it?

·         What assay controls are used?

·         What are the endotoxin specs for water?

·         How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

·         Water harmonization that has occurred

·         Water Micro TM "Dis-Harmonization"

·         A little about Biofilm

·         Biofilm diversity in water systems

·         Micro TM options and evaluation protocol

·         The good and bad of Micro harmonization

·         Where RMMs can fit in

·         Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

·         Microbial Enumeration Issues with High Purity Water Systems

·         Biofilm enumeration issues (planktonic vs surface)

·         Traditional cultivative approach issues

·         Validation of your test method

·         Alternative TM choices (advantages/disadvantages)

·         Significance of water isolates

·         Sampling issues

·         Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

·         Gathering and assessing existing data and symptoms

·         Considering user opinions

·         Investigation approach elements

·         Recognizing red herrings/false positives

·         Recognizing possible root causes

·         Water system contamination case studies

·         Parting kernels of water system wisdom

Lecture 10:

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

·         PW, WFI, Pure Steam micro specifications?

·         <1231> Starting water issues

·         <1231> Misunderstood issues clarified

·         <1231> Microbiological test issues clarified

·         <1231> Suggested micro test method

·         <1231> Micro Specifications

·         <1231> Alert and Action Levels and max's

·         Recent/Upcoming USP water changes

·         Discrepancies between pharmacopeia's

Speaker:

Teri C. Soli, Ph.D.

Principal Consultant, Soli Pharma Solutions

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering training, auditing, and troubleshooting expertise covering water systems, contamination control, sterilization, aseptic processing, and microbiological laboratories. He has 38 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.

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

He is beginning his fourth 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide as well as coauthor USP's comprehensive "water bible', Chapter <1231> "Water for Pharmaceutical Purposes". As a recognized global expert in contamination and biofilm control in the pharmaceutical setting and accomplished presenter, Dr. Soli speaks at numerous conferences and webinars. He has authored numerous articles in Pharmacopeial Forum and other publications as well as chapters in books and industry guides published by PDA and ISPE.

Location: Hyderabad, India Date: April 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Taj Banjara

Address: Road No.1, Banjara Hills, Mithila Nagar, Banjara Hills, Hyderabad, Telangana 500034, India

Price:

Register now and save ₹ 2000. (Early Bird)

Price: ₹ 14,000 (Seminar for one Delegate)

Until March 15, Early Bird Price: 14,000 from March 16 to April 08, Regular Price: 16,000

Registration Details:

NetZealous - GlobalCompliancePanel

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Bangalore - 560078 Karnataka, INDIA

Phone:  1800 425 9409 

Fax:  080-25149544 

smanzoor@netzealous.com

http://www.globalcompliancepanel.in/

Registration Link – http://www.globalcompliancepanel.in/control/pharmaceutical-water-systems-Hyderabad?channel=mailer&camp=seminar&AdGroup=blogger_April_2017_SEO

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Statistics for the Non-Statistician: Is it necessary

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant, but a slightly deeper look will make one understand that statistics for the non-statistician is indeed important, and has uses that help to make important contributions to the organization in which they work.

For understanding processes

Statistics for the non-statistician is important because we need statistics in the course of our professions while taking important decisions in business. For those working in the corporate world, statistics for the non-statistician becomes an important tool and skill with which a deeper understanding can be made of the statistical tools and techniques that employees routinely use in an organization. Using these tools, the professional has a greater understanding of the important parameters and pointers of the business and how to bring about improvements in the quality of a firm's process and product.

Why statistics is important for the non-statistician can also be understood from the fact that when statistics is not properly analyzed, i.e., when statistical analysis is not performed insightfully as a result of a lack of full understanding of the statistical principles and processes by the employees; the organization faces a number of problems. These range from the possibility of facing the risk of producing a poor quality product. Such a product severely retards its ability to deliver a high quality product, as a result of which there is a heavy negative impact on the organization’s bottom line, as well as a blow to its reputation.

Get to understand the importance of statistics for the non-statistician

The importance of statistics for the non-statistician can also be understood from the fact that its knowledge helps regulatory professionals meet regulatory compliance requirements without hassles. To get a clear understanding of the ways in which statistics for the non-statistician helps organizations overcome many challenges, a seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar on statistics for the non-statistician, Steven Walfish, the founder and President of Statistical Outsourcing Services, who brings nearly 20 years of industrial experience providing statistical solutions to complex business problems, will be the Director. To enroll for this seminar, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900742SEMINAR?blogger_SEO. The "Statistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

It is all about practice

Practice is at the root of understanding statistics for the non-statistician. Constant practice is the mantra for employees to attain proficiency in statistics. They need a little bit of initiative, familiarity and some real-world example data sets. Employees who need training on statistics for the non-statistician need an understanding of the most common statistical tools and terms.

They need to understand

a.      how to use statistics to properly trend data

b.     support the annual product review

c.      justify process changes

d.     set product specifications.

The aspects of statistics that employees need to be familiar with

Employees who want to learn how statistics works for the non-statistician need to be able to make use of statistical software packages and understand the role of software in statistical analysis and statistical process control. They also need to have the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements.

The result of this kind of familiarization is that organizations can perform their core functions and still be in alignment with statistical processes that are necessary for staying ahead of the competition. This is what statistics for the non-statistician entails.

The course on statistics for the non-statistician is immensely useful to professionals and supervisors in medical devices, diagnostics, pharmaceuticals and the biologics fields.