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  • Excel Formulas and Functions in Mastering

    Overview: Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job. Why should you Attend: Although it is perfectly possible to use Excel without ever creating a formula or using a function, if you don't, you're missing out on a huge part of the application's power. Formulas and functions will automate your calculations and save you a ton of time. No more using your fingers. No more mental arithmetic. Areas Covered in the Session: Creating formulas to perform mathematical calculations Copying formulas and the difference between absolute and relative references Assigning names to cells and using them in formulas Who Will Benefit: Any Excel user who needs to go beyond the basics of using formulas or simply wants to become more comfortable and productive in using Excel formulas and functions. Any Excel user who deals with large lists needs these tools and techniques to effectively manage the lists and become more productive. Nearly all Excel users, except for those just getting started, are candidates for this webinar. Speaker Profile: Mike Thomas has worked in the IT training business since 1989. He is a subject matter expert in a range of technologies including Microsoft Office and Apple Mac. In 2012 Mike founded theexceltrainer.co.uk where he has produced nearly 200 written and video-based Excel tutorials. He has recorded several Excel training courses for pluralsight.com and in his career delivered hundreds of courses and webinars on a wide variety of technology-related topics. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • IAFP's European Symposium on Food Safety

  • Balancing Customer Satisfaction With Security Issues

    Overview: Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank entries into the marketplace, financial institutions have been playing more defense than offense. Why should you Attend: This webinar is designed for professionals in every bank and credit union area to develop and maintain payments as the core business practice for their customers. Every transaction includes a payment of some sort and the banking industry owns the settlement process, for now. Areas Covered in the Session: S.W.O.T Strengths that banks should exploit Weaknesses that banks should shore up Opportunities for banks to take advantage of Threats that banks cannot ignore Who Will Benefit: Payments Professionals Operations Managers Financial Officers Risk Officers Internal Auditors Speaker Profile: Ray Graber has a deep and thorough understanding of banking, technology, and finance. His business experience includes banking technology research at TowerGroup; best practices internet security, policies, and procedures at FleetBoston Financial; wire transfer operations and product launches at Citibank and BankBoston; and treasury operations for a $325 million public company. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Food Fraud Conference - Global Understanding Towards Global Prevention and Mitigation of Food Fraud

    The Quebec Association for Food Protection (AQIA) is a Strategic Partner of this conference.

    Keynote lectures, presentations and panel discussions gathering experts from renowned organizations such as: 

    • Queen’s University, Belfast, UK
    • Université Laval, Québec, Canada
    • China National Centre for Food Safety Risk Assessment (CFSA)
    • Mars Global Food Safety Centre, China
    • National Measurements Institute, Australia
    • Food Safety Authority of Ireland (FSAI)
    • FERA Ltd., UK
    • Food and Agriculture Organization of the United Nations (FAO)
    • United Nations Industrial Development Organization (UNIDO)
    • AOAC International
    • Agence canadienne d’inspection des aliments (ACIA)
    • Food Integrity Project (supporté par l’UE)
  • Microbiology and Food Safety Course

    • Date April 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Los Angeles, CA
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • Missouri Milk, Food and Environmental Health Association 2017 Annual Meeting

    • Date April 4, 2017 – April 7, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Springfield, MO
    • Website http://www.mmfeha.org
  • Biologics Facility Design & Pharmaceutical Regulatory Aspects - 2017

    Overview: This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them. Why should you Attend: The attendee will learn what is important in facility design from the FDA and regulatory standpoint. The attendee will understand what FDA looks for during a facility inspection. The attendee will be able to minimize possible design errors which are difficult and expensive to fix post-build. The attendee will understand what FDA looks for in reviewing the facility design and the flow patterns. Areas Covered in the Session: Best design practices for Pharma facilities Best design practices for biologics facilities Regulatory compliance for Pharma and biologics facilities design Flow patterns and cross contamination controls Who Will Benefit: Compliance Manager Facility Manager Validation Manager Regulatory Manager Design Team/Architects Speaker Profile: John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Quality of their products by Statistical Process Control - 2017

    Overview: This webinar will be focusing on statistical process control as companies want to improve the quality of their products and to improve product quality need to be structured in such a way that they have a reasonable chance of success. Why should you attend: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most successful method available for such endeavors is called SPC (statistical process control). Areas Covered in the Session: Definition of relevant terms Types of control charts Calculation of control limits for an XbarR chart Rules for detecting "out of control" Sampling Process Capability Indices (Cp, Cpk, Pp, Ppk) SPC Program implementation Who Will Benefit: QA/QC Supervisor Process Engineer Manufacturing Engineer QC/QC Technician Manufacturing Technician Speaker Profile: John N. Zorich has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • What to Do When It's Not a Bell Curve - 2017

    Overview: Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution. Why should you Attend: Almost all traditional industrial statistical methods rely on the assumption that the critical to quality (CTQ) characteristic follows the normal or bell curve distribution. The bell curve is far more common in textbooks than it is in real factories, where processes often follow other distributions. Areas Covered in the Session: SPC charts can be created that work properly for non-normal distributions and have the same false alarm risk as the traditional Shewhart chart for a normal distribution. Process performance dices can be calculated that reflect accurately the nonconforming fraction (or defects per million opportunities) for non-normal distributions. Who Will Benefit: Manufacturing Quality Engineers Managers Speaker Profile: William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, TOC World 2004, and other national conferences on productivity and quality. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Preparation for GMP Inspections by Regulatory Agencies - 2017

    Overview: This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections, rehearsals and preparation for successful facility inspections, and response to findings by regulatory agencies. Why should you Attend: Good manufacturing practice (GMP) is the minimum standard that a manufacturer must meet in their production processes. This webinar will review what to expect during the Agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection. Areas Covered in the Session: Types of Inspections (for cause, pre-approval, periodic ) > API & FDF Notification Timing Foreign Facilities What to expect during Inspection Do a company audit as the FDA would (fall dress rehearsal) Make adjustments as needed/address issues/take needed actions Managing the Inspection Inspection on follow-up Who Will Benefit: Design Engineers Manufacturing Supply chain Technical operations Quality control Quality assurance Regulatory affairs Speaker Profile: Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Kansas Environmental Health Association 2017 Spring Conference

    • Date April 6, 2017 – April 7, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Junction City, KS
    • Website http://www.keha.us
  • Ontario Association for Food Protection 2017 Spring Meeting and Symposium

    • Date April 6, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Mississauga, Ontario, Canada
    • Website http://www.ofpa.on.ca/
  • Supplier Management Conference for Medical Device Manufacturing in HONG KONG

    Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG). This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management. One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers. This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process. Areas Covered in the Session: • Understand FDA QSR and ISO 13485 requirements for supplier management • Creating a Risk-based Multi-tier supplier classification system • Understand when suppliers have to register and list with the FDA • Defining and using supplier Metrics • Explain the link between design control and purchasing data • Develop an risk-based supplier management process o Incorporating supplier regulatory and safety risk o Incorporating supplier business risk • Create supplier measurement and monitoring systems • Understand the how to develop and implement supplier controls • Create a risk based Value-added system for supplier audits • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body • Creating acceptance criteria and understand how that fits into your supplier control process Who will benefit: • Quality Managers • Quality Engineers • Audit Managers • Supplier Engineers • Internal quality auditors • Supplier auditors • Quality associates • Quality Specialists • Regulatory Compliance Managers Agenda: Day 1 Schedule Lecture 1: Introductions Lecture 2: Fundamentals Regulatory Requirements • FDA Requirements • ISO 13485 requirements • Understanding the role of the Global Harmonization Task Force Guideline • Understanding NBOC Guideline and why it should be used Lecture 3: Planning the Supplier Management Program • Supplier Classification • Supplier QA agreements what are they and why are then Day 2 Schedule Lecture 1: Planning Supplier Selection Lecture 2: Potential Suppliers Lecture 3: Supplier Selection Lecture 4: Implementing Supplier Controls Lecture 5: Monitoring, Measuring, and Evaluation • Periodic Monitoring • Re-evaluations Lecture 6: Supplier Audits - where do they add value • Planning your supplier audit schedule • How Notified Body unannounced audits affect your contract manufacturer • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits Lecture 7: Feedback and Communication • Supplier meetings: Partnering with Key suppliers • Supplier Corrective Actions Lecture 8: Evaluating your current program to see how it measures up to regulatory Expectations Speaker: Betty Lane, Founder and President, Be Quality Associates, LLC Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University. Location: Hong Kong Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM Venue: INTERCONTINENTAL HONG KONG Address: 18 Salisbury Road, Kowloon, Hong Kong Price: Price: $1,695.00 (Seminar Fee for One Delegate) Until February 28, Early Bird Price: $1,695.00 from March 01 to April 04, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900878SEMINAR?channel=mailer&camp=seminar&AdGroup=foodprotection_April_2017_SEO Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • 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: Singapore Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Mandarin Orchard Singapore Address: 333 Orchard Road, Singapore 238867 Price: Price: $1,695.00 (Seminar Fee for One Delegate) Until March 6, Early Bird Price: $1,695.00 from March 7 to April 4, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900882SEMINAR?channel=mailer&camp=seminar&AdGroup=foodprotection_april_2017_SEO Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • Introduction to Food Microbiology

  • 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 NetZealous Services India Pvt. Ltd. Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, 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=foodprotection_April_2017_SEO Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia
  • Zurich 2017 - Medical Device Manufacturing Conference

    Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supplier management program. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The C stands for current, meaning what the FDA considers the current state of the art in the areas they regulate. Also European Notified Bodies also periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG). This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management. One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers. This seminar will review requirements and expectation of the FDA and European Notified Bodies for supplier management, and then how to incorporate these into your own supplier management process. Areas Covered in the Session: • Understand FDA QSR and ISO 13485 requirements for supplier management • Creating a Risk-based Multi-tier supplier classification system • Understand when suppliers have to register and list with the FDA • Defining and using supplier Metrics • Explain the link between design control and purchasing data • Develop an risk-based supplier management process o Incorporating supplier regulatory and safety risk o Incorporating supplier business risk • Create supplier measurement and monitoring systems • Understand the how to develop and implement supplier controls • Create a risk based Value-added system for supplier audits • How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body • Creating acceptance criteria and understand how that fits into your supplier control process Who will benefit: • Quality Managers • Quality Engineers • Audit Managers • Supplier Engineers • Internal quality auditors • Supplier auditors • Quality associates • Quality Specialists • Regulatory Compliance Managers Agenda: Day 1 Schedule Lecture 1: Introductions Lecture 2: Fundamentals Regulatory Requirements • FDA Requirements • ISO 13485 requirements • Understanding the role of the Global Harmonization Task Force Guideline • Understanding NBOC Guideline and why it should be used Lecture 3: Planning the Supplier Management Program • Supplier Classification • Supplier QA agreements what are they and why are then Day 2 Schedule Lecture 1: Planning Supplier Selection Lecture 2: Potential Suppliers Lecture 3: Supplier Selection Lecture 4: Implementing Supplier Controls Lecture 5: Monitoring, Measuring, and Evaluation • Periodic Monitoring • Re-evaluations Lecture 6: Supplier Audits - where do they add value • Planning your supplier audit schedule • How Notified Body unannounced audits affect your contract manufacturer • What you should do to prepare yourself and your contract manufacturer for unannounced Notified body audits Lecture 7: Feedback and Communication • Supplier meetings: Partnering with Key suppliers • Supplier Corrective Actions Lecture 8: Evaluating your current program to see how it measures up to regulatory Expectations Speaker: Betty Lane, Founder and President, Be Quality Associates, LLC Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University. Location: Zurich, Switzerland Date: April 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Price: $1,695.00 (Seminar Fee for One Delegate) Until February 28, Early Bird Price: $1,695.00 from March 01 to April 08, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900880SEMINAR?channel=mailer&camp=seminar&AdGroup=foodprotection_April_2017_SEO Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • FSPCA Preventive Controls for Human Food

    • Date April 11, 2017 – April 13, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Fresno, CA
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • ILSI SEA Region Scientific Forum 2017: "Nutrition and Food Safety - Perspectives & Challenges for ASEAN"

    This half-day Scientific Forum, held in conjuntion with the ILSI SEA Region Annual Meeting 2017, aims to discuss selected key public health and scientific topics that relate to nutrition, food safety, sustainable agriculture, and new food technologies.

  • Acceptance Sampling by Variable inspections - 2017

    Overview: This presentation covers the methods in Z1.9 and shows how to use most common choice, standard deviation unknown. The presentation explains how a simple statistical calculator easily provides the needed sampling statistics. Why should you Attend: If you are responsible for any acceptance activities, such as incoming inspection, you need to evaluate them for cost reduction opportunities. One viable alternative, Z1.9, applies when the inspector measures actual values and converts them to pass/fail to use Z1.4 or c=0. The sample sizes may be too large. This presentation will help you understand Z1.9 and determine if it a better choice. Who Will Benefit: Quality Engineers Production and Process Engineers Manufacturing Engineers Design Engineers Purchasing Managers Quality Managers Supplier Quality Engineers Quality Supervisors Quality Inspectors Speaker Profile: Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com