Sign for Notice Everyday    Sign Up| Sign In| Link| English|

Our Sponsors

    Receive Latest News

    Feedburner
    Share Us


    2-day In-person Seminar on The A to Z's of Writing and Enforcing Effective SOPs (Standard Operating Procedures) at Atlantic city, NJ

    View: 120

    Website http://bit.ly/1eWX2lm | Want to Edit it Edit Freely

    Category Seminar, Health, Medical, Pharma, Clinical

    Deadline: April 24, 2014 | Date: April 25, 2014-April 26, 2014

    Venue/Country: Atlantic City NJ, U.S.A

    Updated: 2014-03-04 16:17:36 (GMT+9)

    Call For Papers - CFP

    Overview:

    This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, and efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

    Why should you attend?

    SOPs are important in pharmaceutical industry. Most of GMP violations are due to inadequate SOPs or SOPs that are not well written. Any critical GMP activities that affect quality and safety of the drug products will require written procedures. This course will provide participants with tools to write effective SOPs. This course will also discuss the regulatory requirements of documentation and record management systems for SOPs used in GMP operations.

    This 2-day course will emphasize practical issues such as the role of SOP in GMP operations, how to improve and maintain existing documentation system, and how to determine gaps or overlaps to strengthen the existing system.

    After this course, you will be able to understand the critical role SOPs play in daily operation, strengthen and maintain your current SOP system and organize effective training for Sops. This course is filled within interactive exercise to help participants develop practical understanding of this important tasks and a logical approach to develop their own SOP system.

    Areas Covered in the Session:

    ? FDA requirements and Expectations

    ? Documents including SOPs

    ? General controls for Documentation

    ? Determine the needs of new SOP

    ? Determine the responsibility for SOP

    ? Different types of SOPs

    ? Format and writing techniques for an SOP

    ? Organizing information on an SOP

    ? Management Aspects of SOP

    Day 1 ? Agenda

    Day One

    Lecture 1: FDA requirements and Expectations

    Lecture 2: Documents including SOPs

    Lecture 3: General controls for Documentation

    Lecture 4: Determine the needs of new SOP

    Lecture 5: Determine the responsibility for SOP

    Day 2 ? Agenda

    Day Two

    Lecture 6: Different types of SOPs

    Lecture 7: Format and writing techniques for an SOP

    Lecture 8: Organizing information on an SOP

    Lecture 9: Management Aspects of SOP

    Lecture 10: Training for SOPs

    Who Will Benefit:

    ? Laboratory Analysts

    ? Quality Assurance scientists

    ? QA/QC Analysts

    ? QA/QC Managers

    ? Auditors

    ? Inspectors

    ? Pharmaceutical Development and Manufacturing Personnel

    ? Manufacturers of Raw Materials and Excipients

    ? Contract Laboratory Organization Personnel

    About Speaker:

    David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

    DATE, VENUE & PRICE:

    Location: Atlantic City, NJ| 24th & 25th April 2014| 9 AM to 6 PM

    Venue: WILL BE ANNOUNCED SOON

    Price: $1,295.00

    Register now and save $200. (Early Bird)

    Until March 10, Early Bird Price: $1,295.00

    From March 11 to April 19, Regular Price: $1,495.00

    Contact Information:

    Event Coordinator

    Toll free: 1800 447 9407

    Fax: 302 288 6884

    Email: supportatglobalcompliancepanel.com

    Website: https://www.globalcompliancepanel.com

    LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php

    EVENT Link ? http://bit.ly/1eWX2lm

    Net Zealous LLC,

    DBA GlobalCompliancePanel,

    161 Mission Falls Lane,

    Suite 216, Fremont, CA 94539, USA


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.