2-day In-person Seminar on The A to Z`s of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems in San Diego CA

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  • 1. Global Net Zealous CompliancePanel 2-day In-person Seminar: The A to Z's of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems By: Teri C. Soli, Principal Consultant, Soli Pharma Solutions Location 1: Washington DC | February 13-14, 2014 Location 2: San Diego CA | May 1-2, 2014 Course "The A to Z's of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems" has been preapproved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. About GlobalCompliancePanel: GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and costeffective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other. www.globalcompliancepanel.com Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till now All rights are reserved © GlobalCompliancePanel.
  • 2. Global 2-day In-person Seminar 2014 CompliancePanel Teri C. Soli, Principal Consultant, Soli Pharma Solutions Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems. Course Outline: Day One - ( 9 AM to 6 PM) 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 Day Two - ( 9 AM to 6 PM) 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  How to figure out what you should validate  Validation of your test method  What happens after the honeymoon is over  Alternative TM choices (advantages/disadvantages)  Is validation ever really over?  Significance of water isolates  Special considerations for lab water systems  Sampling issues  Are packaged waters a viable option?  Establishing Alert/Action Levels and Water Specs and defending 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? 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  What about water use during re-qualifications?  Investigation approach elements  FDA validation expectations  Recognizing red herrings/false positives  Reliance on logic and common sense and the disservice of  Recognizing possible root causes 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 www.globalcompliancepanel.com  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 All rights are reserved © GlobalCompliancePanel.
  • 3. Global 2-day In-person Seminar 2014 CompliancePanel Pricing list: Price for One Delegate pass Price: $1,295.00 February 13-14, 2014 | Washington DC May 1-2, 2014 | San Diego CA Register now and save $200. (Early Bird) Register now and save $200. (Early Bird) Until January 01, Early Bird Price: $1,295.00 Until February 10, Early Bird Price: $1,295.00 From January 02 to February 10, Regular Price: $1,495.00 From February 11 to April 28, Regular Price: $1,495.00 **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. What you get Payment Options: 1. 2. 3. 4. 5.  Credit Card: Use the Link to make Payment by 6. 7. 8. 9. Learning Objectives Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. Networking with industry's top notch professionals Visa/Master/American Express card click on the register now link  Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA  PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884  Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer information Who Will Benefit:  Microbiology Laboratory supervisors and analysts  Facility Engineers responsible for water system design responsible for water sampling and testing  Quality Assurance personnel responsible for water system deviation management and change control or renovation  Validation personnel for water system qualification  Change Control personnel involved in water system changes and repairs  Regulatory and Compliance professionals responsible for FDA interactions  Production Managers involved with water system use for  Process and Utility Engineers responsible for water manufacturing and cleaning system maintenance, repairs, troubleshooting, and excursion mitigation Kindly get in touch with us for any help or information. Contact Information: Event Coordinator Look forward to meeting you at the seminar Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Team GlobalCompliancePanel NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
  • 4. Global CompliancePanel 2-day In-person Seminar 2014 Registration Form: Please use this form to register online, using your American Express, Visa or MasterCard. To get discounts on group attendance, please call us on1800 425 9409 Call us on 1800 447 9407 or fax your PO to 302 288 6884 Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at 100 8425 9409 or email us at support@globalcompliancepanel.com Please fill this form out and include attendee and payment details in it and fax it to 302 288 6884 Terms and Conditions Your registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clarifications or doubts on this issue. Cancellations and Substitutions If you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period. A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this. You are allowed to make substitutions at any time till the start of the event. The substituting person should be present well in time for the event with proper written communication and company identity. If registering on the date of the seminar, please make sure you pay for the event using your credit card or check just before the start of the event. To such attendees, we may not be able to give the conference materials on the spot. In such an event; we will send the same after the conclusion of the seminar. No-shows will not be reimbursed. If GlobalCompliancePanel cancels an event, we will not be reimbursing any airfare, accommodation, other costs or losses that the registrants may have incurred. GlobalCompliancePanel reserves the right to change topics and speakers without notice. Seminar Topic:...................................................................................................................................................... Date:..................................................................................................................................................................... Attendee 1 : Name ............................................... Title ..................................................... Email .................................................. Attendee 2 : Name ............................................... Title ..................................................... Email .................................................. Attendee 3 : Name ............................................... Title ..................................................... Email .................................................. Attendee 4 : Name ............................................... Title ..................................................... Email .................................................. Company Information Organization ....................................................................................... Address .............................................................................................. City ........................................ State ........................ Zip.................... Country .............................................................................................. Phone ........................................... Fax ............................................. Payment Options Check enclosed, payable in U.S. funds to NetZealous LLC, DBA GlobalCompliancePanel Charge to: Visa MasterCard American Express Credit card no. ............................................................................ Expiration date ............................................................................ CVV Number .............................................................................. Total amount $ ............................................................................ Signature .................................................................................... (Signature required on credit card and bill-me orders.) NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: +1-800-447-9407 Toll free (US): +1-800-447-9407 / Fax (US): 302 288 6884 www.globalcompliancepanel.com Print name .................................................................................. Bill me/my company $ ............................................................ Purchase order # ........................................................................ (Payment is required by the date of the conference.) Please ll this form with attendee details and payment details and fax it to 302 288 6884 All rights are reserved © GlobalCompliancePanel.