2-day In-person Seminar on Verification/Validation - Product, Process, Software and QMS at Las Vegas

							                                                                                                                     Net Zealous


 USA Seminar 2013 at Las Vegas

  Verification / Validation -- Product,
  Process, Software and QMS
 by    John E. Lincoln
       On 17th and 18th January, 2013 at Las Vegas




About GlobalCompliancePanel:
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are
simple while being relevant and cost-effective 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.

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.



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USA Seminar 2013 at Las Vegas

             James E. Russell
             Director of Regulatory Affairs, RJR Consulting Inc



About Speaker:
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over
30 years experience in U.S. FDA-regulated industries, 16 of which as a full-time consultant. John
has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France,
Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs,
QMS problem remediation and FDA responses, new / changed product 510(k)s, process /
product / equipment V&V including QMS and software validations, ISO 14971 product risk
management files / reports, Design Control / Design History Files, Technical Files. He's held
positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and
VP (R&D). In addition, John has prior experience in military, government, electronics, and
aerospace. He has published numerous articles in peer reviewed journals, conducted workshops
and webinars worldwide on V &V, CAPA, 510(k)s, risk analysis / management, FDA / GMP audits,
root cause analysis, and others. John is a graduate of UCLA.




Venue

                                                            Date and Venue:

                                                            January 7th and 8th, 2013 at Las Vegas




                                                            WILL BE ANNOUNCED SOON




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 USA Seminar 2013 at Las Vegas

 Overview:
 Review the company Master Validation Plan for major key inputs and CGMP deficiencies. Address
 the FDA's newer and tougher regulatory stance.

 Prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case
 elements / scripts. Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and
 product risk management. Evalute different field-tested, U.S. FDA-reviewed V&V protocols; how to
 employ equipment / process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents
 per ASTM E2500, all against a background of limited company resources.

 Review a matrix that simplifies "as-product", in-product", process and equipment, et al, software
 VT&V, to assure key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are
 considered. Make practical application in two hands-on sessions.


Seminar Content:                                                           Conference Timings: 9am to 6 pm EST
Day 1 - 17th January 2013                             Day 2 - 18th January 2013

 Lecture 1: Master Validation Planning and            Lecture 9: Software V&V documentation
            the Master Validation Plan(s)                        "model"

 Lecture 2: Product, Process / Equipment              Lecture 10: Software V&V protocols –
            Hardware V&V                                          "black box", "white box"

 Lecture 3: Product / Device V&V                      Lecture 11: Electronic Records and
                                                                  Electronic Signatures (Part
 Lecture 4: TSoftware V&V                                         11)

 Lecture 5: Quality Management System /               Lecture 12: Summary of morning
            21 CFR Part 11 V&V                                    discussion

 Lecture 6: Summary of morning                        Lecture 13: Group activity on 1) hardware
            discussion                                            / equipment, and 2) software
                                                                  V&V protocols
 Lecture 7: Group activity on the MVPs
                                                      Lecture 14: Review of group activity and
 Lecture 8: Review of group activity and                          Q&A
            Q&A
                                                      Lecture 15: Course summary discussion

                                                      Lecture 16: Summary of morning
                                                                  discussion

                                                      Lecture 17: Group activity on the MVPs

                                                      Lecture 18: Review of group activity and
                                                                  Q&A


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USA Seminar 2013 at Las Vegas
What you get:
1. Learning Objectives                                                               Pricing List:
2. Participation certificates                                                        1. Price for One Delegate pass
3. Interactive sessions with the US expert                                              $1695
4. Post event email assistance to your queries.                                        (Between December 18th to January 16th)

5. Special price on future purchase of web based trainings.                          --------------------------------------
6. Special price on future consulting or expertise services.                         2. Early bird price for one Delegate
7. Special price on future seminars by GlobalCompliancePanel.                           pass $1495
                                                                                       (Between November 26th to December
8. Seminar Kit – includes presentation handout, ID card, brochure,                       17th)
   trainings catalog, notepad and pen.                                               --------------------------------------
9. Networking with industry's top notch professionals                                3. For discounts on multiple
                                                                                        registrations, contact customer
                                                                                        care at 1800 447 9407


                                            Companies that will benefit:
                                             Drug and Biologics Companies
                                                                                    Professionals who will benefit:
                                             PAT Teams
                                                                                     Executives/Managers within Dietary
                                             Process Development
                                                                                      Supplement or Natural Product
                                                                                      companies
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    Event Coordinator
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    Fax: 302 288 6884                                                            us for any help or
    Email:                                                                       information.
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    NetZealous                                                                   Team
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