The A to Zs of Microbial Control, Monitoring Validation

Dec 09, 17 The A to Zs of Microbial Control, Monitoring Validation

The A to Zs of Microbial Control, Monitoring Validation

Overview: This program is designed to give a microbiology-concentrated education about all areas of drinking water systems and just how biofilm manages to thrive there. Prior microbiological education or schooling, though a plus, isn’t a necessity because engineers and various other nonbiologists also need this schooling if they’re involved with any facet of water systems.

The instructor provides the necessary background had a need to understand why very important subject material. This understanding is vital to the correct design, validation, procedure, monitoring, maintenance, troubleshooting, and excursion investigations of a higher purity water program. Without this understanding, drinking water system control includes a group of rules that frequently don’t work and will cause very costly program downtime or even item recalls, and leaves an individual without a clue in regards to what went incorrect or how exactly to effectively repair it so that it doesn’t recur.

Areas Covered in the Program:The “real” tale behind some typically common water system style and control mythsBiofilm properties, resistances, susceptibilities and examplesWater program sanitization to regulate biofilmWater program microbial enumeration issuesUSP’s take on sampling and microbial enumerationMicrobial enumeration choices/advantages/disadvantagesHow to find the best microbial enumeration technique and “validate” itWater Program Validation and Modification ControlImproving outcomes and lowering the frequency of excursion investigationsHow to execute successful Water Program excursion investigations and troubleshooting, with research study examplesWhat USP actually says about all thisCourse Modules & Content Details:

Day 1, April 19, 2012

Lecture 1: WHY IS Water Systems Have got Microbial Quality ProblemsUnderstand biofilm essentials and how it developsUnderstand the influence of biofilm on the commonly used purification device operationsUnderstand how various commonly used microbial control strategies function (or don’t function) to regulate biofilm developmentUnderstand the how, where, and just why of microbial monitoring, actions amounts, etc.Debunk a couple of water program mythsGet answers to your own personal drinking water program questionsLecture 2: Successful Sanitization Approaches for Trouble-Free of charge Water QualityMaterial and structure limitationsContinuous vs intermittent sanitizationThe need for biofilm removalHow sanitants function (or don’t function)When to sanitizeTroubleshooting sanitization problemsLecture 3: Water Program Validation by Logic Rather than TraditionWhy validate a drinking water system’simple ground rules for water systems before you validate themMicro Test Technique “validation”Minimal validation expectationsHow to determine what you ought to validateWhat happens following the honeymoon is certainly overIs validation ever really more than?Particular considerations for lab water systemsAre packaged waters a practical option?Lecture 4: Implementing Adjustments to a Validated SystemPurpose of a Modification Control plan – a help, not really a hindranceWhen is a modification major vs small, requiring full vs small re-qualification?What about drinking water use during re-qualifications?FDA validation expectationsReliance on logic and good sense and the disservice of precedent and paradigmsAdditional useful tipsLecture 5: Reducing Drinking water Microbial Excursions & Improving InvestigationsWhat are excursions?Water program dilemma: procedure control or quality control (utility or raw materials), or bothIntended functions of Alert/Action Amounts and SpecificationsInvestigation, necessary and frequently fruitlessExcursion responses and impactCriticality of valves, hoses, & wall plug flushingDiagnosing the foundation of the problemMinimizing needless excursion responses through very best practicesDay 2, April 20, 2012

Lecture 6: Understanding and Controlling EndotoxinWhere will endotoxin come from?What exactly are the properties of endotoxin ?How can you eliminate it?How can you detect it?What assay handles are used?What exactly are the endotoxin specifications for water?How can you control it?Lecture 7: Harmonizing vs Optimizing Drinking water Microbial Testing for Program Quality ControlWater harmonization which has occurredWater Micro TM “Dis-Harmonization”Just a little about BiofilmBiofilm diversity in drinking water systemsMicro TM choices and evaluation protocolThe bad and the good of Micro harmonizationWhere RMMs may fit inParting wisdomLecture 8: Microbial Enumeration Problems with High Purity Drinking water SystemsBiofilm enumeration problems (planktonic vs surface area)Traditional cultivative strategy issuesValidation of your check methodAlternative TM options (advantages/disadvantages)Significance of drinking water isolatesSampling issuesEstablishing Alert/Actions Levels and Water Specifications and defending them to FDALecture 9: Water Program Investigation “How-To’s” and Example Case StudiesGathering and assessing existing data and symptomsConsidering consumer opinionsInvestigation approach elementsRecognizing crimson herrings/false positivesRecognizing possible root causesWater program contamination case studiesParting kernels of drinking water program wisdomLecture 10: What USP Does and Doesn’t Express about PW, WFI, Pure Steam and Micro IssuesPW, WFI, Pure Steam micro specs? Starting water problems Misunderstood problems clarified Microbiological test problems clarified Suggested micro check method Micro Specs Alert and Action Amounts and max’sRecent/Forthcoming USP drinking water changesDiscrepancies between pharmacopeia’sNew drinking water initiatives – need your insight/feedback

Who’ll benefit: This 2-time course is particularly highly relevant to managers, supervisors, and operatives dealing with new responsibilities linked to water, also for experienced drinking water personnel to understand the “true” whys behind what they do as well as perhaps better means of doing things. Particular positions that would advantage are:Microbiology Laboratory supervisors and analysts in charge of drinking water sampling and testingQuality Assurance employees in charge of water system deviation administration and transformation controlRegulatory and Compliance specialists in charge of FDA interactionsProcess and Utility Engineers in charge of water system maintenance, fixes, troubleshooting, and excursion mitigationFacility Engineers in charge of water system style or renovationValidation employees for water program qualificationChange Control employees involved with water system adjustments and repairsProduction Managers associated with water system make use of for making and cleaningLaboratory Managers and Supervisors in charge of lab drinking water systems and other drinking water sources

T.C. Soli, is normally a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (), and since learning to be a regular consultant, has served customer products and FDA-regulated sectors with schooling and troubleshooting knowledge covering drinking water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory functions, and provides served as a pharmaceutical professional witness in a number of “contamination” litigations. Ahead of full period consulting, he previously 25 years of different “Big Pharma” operating firm experience. During his 31+ year profession he provides lectured extensively at conferences, authored many papers and lately written several reserve chapters linked to water program microbiology for USP, PDA and ISPE publications. He’s presently serving in his third five-calendar year term on USP Professional Committees in charge of Pharmaceutical Waters by which he authored the entire rewrite of USP Chapter which many consider to end up being USP’s “pharmaceutical drinking water bible”.

Date & Venue:

April 19th and April 20th 2012 in Pennsylvania, Courtyard by Marriott Philadelphia Downtown 8 AM PDT to 5 PM PDT

Price: $1,695.00



Phone: 800-425-9409 Fax: 302-288-6884

read more

Seminar on Regulatory Compliance For Dietary Supplements in The US,

Dec 08, 17 Seminar on Regulatory Compliance For Dietary Supplements in The US,

Seminar on Regulatory Compliance For Dietary Supplements in The US, EU And Canada at Boston

This 2-day interactive live seminar will review the regulations that impact HEALTH SUPPLEMENTS in america, EU and Canada and talk about how exactly to verify that products are compliant with these regulations. Differences with meals and medication regulation in these countries will end up being noted aswell. We may also cover what qualifies as a dietary health supplement or dietary ingredient, how exactly to ensure GMP compliance along with complete requirements for labeling and appropriate marketing claims. An revise on current occasions within the Supplement sector and the potential impacts to Producers and Distributors in america, EU and Canada may also be presented and discussed.

Course Outline: Day 1:

Dietary Health supplement Regulation in the U.S.

Lecture 1: Dietary Health supplement Overview

Exactly what is a dietary supplement?

Supplements vs.


OTC Drugs

Conventional Foods

Medical foods

Natural products

Herbal medicinal products

Lecture 2: Agencies and Regulatory Structure

FDA Structure regarding HEALTH SUPPLEMENTS

Industry Groups

Lecture 3: Background of Dietary Supplement Regulation

Early History


Code of Federal Regulations

Lecture 4: Manufacturing Considerations

Company & Facility Registration

GMP Requirements

GMP inspections

Lecture 5: Dietary Ingredients

What qualifies simply because a dietary ingredient?

Aged dietary ingredients vs. New nutritional ingredients

New Dietary Component Notification (NDIN)

Updated New Dietary Component Guidance from FDA

Lecture 6: Labeling Considerations

Display Panels & Layout

Supplement Facts Panel

Labeling Claims

Health claims

Disease Claims

Structure/Function claims


Notification of labeling promises to FDA

Dietary Supplement Labeling Act

Lecture 7: Advertising Considerations

FDA vs. FTC jurisdiction


Expressed vs. Implied Claims

Exercises & examples


Claim Substantiation


Course Outline: Day 2:

Food Health supplement regulation in the EU

Lecture 8: Overview

Exactly what is a food supplement?

Borderline products

Medicinal Foods

Lecture 9: Companies and Regulatory Structure

EU Regulatory Structure

Industry Groups

Lecture 10: Supplement Regulation

Early History

Food Supplement Directive

Lecture 11: Manufacturing Considerations

Company & Facility Registration

GMP Requirements

Lecture 12: Dietary Ingredients

What qualifies mainly because a dietary ingredient?

Ingredient safety


DRV vs % Daily Value

Lecture 13: Labeling Considerations

Display Panels & Layout

Labeling Claims

Health claims

Disease Claims

Reduced amount of Disease Risk Claims

Nutrition Claims

Notification requirements

Lecture 14: Advertising Considerations


Claim Substantiation

Natural Health Item regulation in Canada

Lecture 15: Overview

Exactly what is a Natural Health Product?

Lecture 16: Companies and Regulatory Structure

Canadian Regulatory Structure

Health Canada

Canadian Health Products Directorate

Lecture 17: Supplement Regulation

National Health Products Regulation

Variations between Canada and US

Supplements monographs

Requirements for pre-market approval

Lecture 18: Production Requirements for Natural Wellness Products in Canada

Lecture 19: Dietary Ingredients

Lecture 20: Labeling Considerations

Lecture 21: Advertising Considerations

Lecture 22: Enforcement and Post-Marketing Surveillance

Who Will Benefit:

Executives/Managers within Dietary Health supplement or Natural Product companies

Regulatory Compliance Experts in the Health supplements or NATURAL BASIC PRODUCTS area

Quality Assurance or Quality Control Professionals

Dietary Supplement or Organic Product Manufacturers & Distributors

Sales/Marketing Staff in the Supplement or Organic Product Industries

read more

Facing A DUI Charge With An Attorney Who Is Schooled

Dec 01, 17 Facing A DUI Charge With An Attorney Who Is Schooled

Facing A DUI Charge With An Attorney Who Is Schooled In The Complex Aspects Of The Law

You should certainly always hire lawyer that has an ample amount of knowledge successfully handling the type of problem or issue you will need resolved. Also when a lawyer has significant credentials and knowledge in confirmed area of laws, that experience might not be of very much assist in some legal matters.

Some lawyers might excel in confirmed section of the law, where they have above typical knowledge and knowledge, but those credentials may not help you now. That isn’t a reflection on the lawyer, or his skills to help in other types of cases, however your most present desires are everything you most need help with.

A lawyer who specializes in estate laws, for example, might not be the best option of counselor to guard you in a criminal case, if the need arise. You would be well advised to search out an lawyer who includes a specialist’s planning in the kind of issues you need help with, particularly if it’s an extremely technical area.

There are various criminal law where lawyers are likely to specialize, so in a criminal case, your counselor must have a lion’s share of experience. You could be seeking out driving under the influence lawyer in Southern California, and that might be a logical choice if you are facing a charge of driving while impaired.

If you have been charged with driving while impaired, it is likely you realize that you need to take appropriate measures just because a DUI charge has devastating implications. Based on where you live, you could be seeking the help of an DUI lawyer in Orange County to greatly help show you through the intricacies of the legal techniques you’ll face.

The set of attorneys in your town is without a doubt lengthy, and unless you’re already acquainted with good DUI attorneys, it will likely be hard to narrow down the list. You might like to consult a relative or friend who provides experienced the same difficulties you are encountering today, and you could perhaps get some good advice.

If zero one you understand has faced an identical charge, you could ask officials at your neighborhood courthouse for an indicator of a lawyer experienced in DUI situations. If you’re discovered guilty of driving while impaired you’re going to encounter fines that may exceed $10,000, so it is a good idea to locate a attorney who might save money.

If your attorney has successfully defended others charged with DUI, there’s a chance that he can do the same for you personally, and perhaps save lots of money as you proceed.

read more

Online Will Kits Got Your Attention? Think Again!

Nov 26, 17 Online Will Kits Got Your Attention? Think Again!

Online Will Kits Got Your Attention? Think Again!

Online advertisers are receiving better with their lure of assisting you produce your will using inexpensive software program or template will products. Wills are not therefore trivial and you ought to take these more significantly. If it had been a simple program or a draft of something much less significant, you might have quickly relied on software program, but much more reaches stake here. An individual mistake with the signature or a miscalculation with unassuming amount can spoil all of your effort and make your intestate.

Benefit of Hiring Estate Lawyers

Estate lawyers offer you highly personalized information on your own wills and estates, that you won’t find with do-it-yourself products. These products advertise that a person with a basic senior high school education can complete the blanks and obtain wills produced, but what they conceal is that somebody with a higher school education might not understand much about condition estate laws.

A will kit addresses the most typical and mundane problems of a will. It generally does not provide for problems that may occur after your demise. To illustrate why don’t we take the exemplory case of taxation statements, if something will not pan out just how your will-package provided for, in that case your benefactors will end up being at the deep end of the pool with an extended legal battle before them. In short, so that they can save a couple of hundred dollars you will force your family in to the uncertainties of legal tussles.

To get all of your loose leads to order you will need the professional provider of an estate attorney.

With out a real person to assist you with your will, now there can’t be reassurance. Do-it-yourself kits include no liabilities and can not really bear any responsibility if the testator misinterprets a clause or makes the incorrect choice for having less foreseeing the outcomes of his activities.

A common practice among users of such products is to obtain forms checked by Estate attorneys. The provider of an estate attorney does not come free of charge and the fees are simply shy of a complete blown will making program. Therefore, we believe that it is only sensible to walk into any office of an estate attorney and obtain your will manufactured in the most professonally executed manner possible.

read more

HIPAA Privacy, Security And Breach Notification Compliance – US Seminar

Nov 14, 17 HIPAA Privacy, Security And Breach Notification Compliance – US Seminar

HIPAA Privacy, Security And Breach Notification Compliance – US Seminar 2012 at Boston

Overview: This program is made to provide intensive, two-day time trained in HIPAA compliance, including what’s currently in the rules, what’s changing, and after that have to be addressed simply by covered entities and business associates soon. The session supplies the background and information for just about any manager of health care information privacy and protection to learn what are the most crucial privacy and security problems, what must be completed for HIPAA compliance, and what can occur without compliance.

Areas Covered in the Program:The way the HIPAA Regulations found beObjectives of HIPAA RegulationsPrinciples of HIPAA ComplianceOutline of the HIPAA RulesDefinition of HIPAA Business AssociatesPatient Privileges Under HIPAAPrivacy Obligations Under HIPAAChanges to the HIPAA Personal privacy RulesPrinciples of Info SecurityHow to execute a HIPAA RISK OF SECURITY AnalysisPolicies and Methods for HIPAA ComplianceWhat Is a HIPAA Audit and How exactly to Plan OneHow EHRs, Meaningful Make use of, and HIPAA Are RelatedTypical Risk Problems and Mitigation PlanningThe New Threats: Portable Products and Sociable MediaUsing Self-Audits and Drills to Hone Your Compliance ResponseUsing Documentation to Streamline Continuous Compliance ReadinessCourse Modules & Content Details:

Day One :Day 1 models the stage with a synopsis of the HIPAA regulations and continues with demonstration of the specifics of the Personal privacy Rule, latest and expected adjustments to the guidelines, and the fundamentals of the Security Guideline.

Day 1, May 17th, 2012

Lecture 1: Summary of HIPAA RegulationsThe Origins and Reasons of HIPAAPrivacy Rule Background and ObjectivesSecurity Rule Background and ObjectivesBreach Notification Requirements, Benefits, and ResultsLecture 2: HIPAA Privacy Rule Concepts, Policies and ProceduresPatient Privileges under HIPAALimitations on Uses and DisclosuresRequired Guidelines and ProceduresTraining and Documentation RequirementsLecture 3: Latest and Proposed Adjustments to the HIPAA RulesNew Penalty StructureNew Audit RequirementsNew Individual RightsNew Obligations for Business AssociatesLecture 4: HIPAA Protection Rule PrinciplesGeneral Guidelines and Flexibility ProvisionsThe Part of Risk AnalysisSecurity SafeguardsTraining and Documentation

Day 2, May 18, 2012

Day Two: Day time two begins with an in depth study of HIPAA Security Guideline requirements and what can be done to survive audits by the united states Department of Health insurance and Human Solutions, including an study of how risk evaluation is used to operate a vehicle compliance by the systematic study of info flows and mitigation of dangers discovered. Finally, your day concludes with a program on the fundamental activities of documenting guidelines, procedures, and activities, teaching personnel and managers in the problems and policies they have to find out about, and examining compliance readiness through drills and self-audits.

Lecture 5: HIPAA Protection Policies and Methods and AuditsHIPAA Security Plan FrameworkSample Security Plan ContentRecommended Degree of Detail for Guidelines and ProceduresUsing Good Guidelines and Methods to Survive AuditsLecture 6: Risk Analysis for Protection and Meaningful UsePrinciples of Risk Evaluation for Information SecurityInformation Protection Management ProcessRisk Evaluation MethodsRisk Analysis ExampleLecture 7: Risk Mitigation and Compliance RemediationTypical Protection RisksSocial Press and PrivacyDealing with Lightweight Devices and Remote control AccessCompliance PlanningLecture 8: Documentation, Teaching, Drills and Self-AuditsHow to arrange and Make use of Documentation to Your AdvantageTraining Strategies and Compliance ImprovementConducting Drills in Incident ResponseSelf-Auditing of Compliance

Who will benefit:Information Protection OfficersRisk ManagersCompliance OfficersPrivacy OfficersHealth Info ManagersInformation Technology ManagersMedical Workplace ManagersChief Financial OfficersSystems ManagersLegal Counsel andOperations Directors

Jim Sheldon-Dean may be the founder and director of compliance solutions at Lewis Creek Systems, LLC, a Vermont-based consulting company founded in 1982, providing information privacy and protection regulatory compliance solutions to healthcare firms and businesses through the entire Northeast and nationally. Sheldon-Dean’s firm offers a selection of advisory, training, evaluation, policy development, project administration and mitigation solutions for several healthcare providers, businesses, universities, little and huge hospitals, urban and rural mental health insurance and social service companies, health insurance programs and healthcare business associates. He acts on the HIMSS Info Systems Protection Workgroup, the Workgroup for Digital Data Interchange Personal privacy and Protection Workgroup, and co-seats the WEDI HIPAA Improvements sub-workgroup. He’s a frequent loudspeaker regarding HIPAA and info privacy and protection compliance problems at seminars and conferences, including speaking engagements at AHIMA nationwide conventions and WEDI nationwide conferences, and prior to the NY Metropolitan Chapter of the Health care Financial Management Association, Wellness Information Administration Associations of NEW YORK, New York Condition, and Vermont, the Connecticut Medical center Association, and a healthcare facility and Health Program Association of Pennsylvania. Sheldon-Dean has nearly 30 years of encounter in policy evaluation and implementation, business procedure analysis, info systems and software advancement. His encounter includes leading the advancement of healthcare related Internet sites; award-winning, best-selling industrial utility software program; and mission-crucial, fault-tolerant communications satellite television control systems. Furthermore, he offers eight years of encounter doing hands-on medical are a Vermont qualified volunteer emergency medical specialist. Sheldon-Dean received his B.S. level, summa cum laude, from the University of Vermont and his master’s level from the Massachusetts Institute of Technology.

Date & Venue:

May 17th and could 18th 2012 in Boston Marriott Long Wharf8 AM PDT to 5 PM PDT

Price: $1,395.00




Phone: 800-425-9409 Fax: 302-288-6884

read more

Understanding Analytical Test Results- Comparing Two Sets of Data –

Nov 11, 17 Understanding Analytical Test Results- Comparing Two Sets of Data –

Understanding Analytical Test Results- Comparing Two Sets of Data – Webinar By Globalcompliancepanel

Overview: The class covers the understanding the properties of one test outcomes and how they might be compared. There are plenty of issues that arise from a misunderstanding of the properties of one data pieces and the issues are compounded when data pieces are compared. The debate covers the misconceptions and present solutions to allow correct comparisons, while deciding the dangers inherent in decisions predicated on analytical data.

Areas Covered in the Program:Averages and their properties that have an effect on decision proper method to compare collection of sample sizes with the attendant conversation of variation and sample to review the variation seen in two different data to create predictions of intervals for potential data, and the usage of these predictions for environment Will Benefit:Employees in Quality Control Laboratories.Supervisors of workers who all perform analytical assessment.Managers who must produce decisions predicated on analytical data.Planners who all must produce predictions of future functionality based on current check data.Reviewers who have to understand the romantic relationships among analytical data.

Tuesday, March 20, 201210:00 AM PST 01:00 PM EST

Price List:Live : $245.00Corporate live : $995.00Documented : $295.00

Steven S. Kuwahara, Ph.D. may be the founder and Principal of GXP BioTechnology LLC, a consulting company that functions in the areas included in the GLP and GMP of medications, biologics, and nutraceuticals. Steve provides over 30 years of knowledge in supervising quality control laboratories, including an pet testing service, and in executing GLP and GMP audits of inner and external assessment laboratories . Steve provides participated in the advancement of medications and biologicals through all phases of scientific research and final item production.

GlobalCompliancePanel can be an online schooling gateway delivering top quality regulatory & compliance trainings in a straightforward, affordable and in a user-friendly format.

GlobalCompliancePanel offers a wide range of stations for broadcasting and exchange of details through online training, web alerts & debate forums.

GlobalCompliancePanel imparts understanding of guidelines in industry to ensure effective implementation of compliance applications for meeting regulatory needs. The key concentrate of GlobalCompliancePanel is certainly to provide comprehensive and quality schooling for risk administration, regulatory compliances, corporate governance and quality management. Aside from providing excellent schooling to compliance specialists by compliance & consulting professionals, GlobalCompliancePanel would also concentrate on providing

read more