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    SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Start Date : October 23, 2018
    End Date : October 23, 2018
    Time : 8:30 am to4:30 pm

    Phone : (800) 447-9407
    Email : globalcompliancepanel@gmail.com

    Location :
    Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Hwy, Arlington, VA 22202, USA

    Website

    Description


     

    Course “SOP Writing, Training and Compliance in the Pharmaceutical Industry” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

    Overview:

    Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing.

    Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies. To achieve the goal of an SOP that has adequate but not excessive detail, the course will define the parameters of an effective SOP and provide a solid foundation that will have a positive impact on training and job performance. Conversely, the negative impact of poorly written procedures on production and compliance will also be explored. To achieve these ends, the course will explain the use of process excellence tools, as well as interaction with the SOP process owner and/or author to create a robust process and procedure. In addition, the course will demonstrate how to avoid common pitfalls in revising existing procedures.

    It is not widely understood how the writing of a procedure can have a positive or negative impact on training. In this course you will also learn the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training. The training department needs to be in the loop at the start of the SOP development process, so that the SOP and training content can be written with the learner in mind, using adult learning principles and consistent terminology.

    There is a relationship between SOPs, training curricula and employees’ qualification to perform their tasks. Through this course you will also learn how to integrate SOPs effectively into these curricula, which is the proof to internal auditors and regulatory agencies that job positions are correctly identified and documentation exists to demonstrate employees’ qualification to perform their tasks independently.

    This course will also show you how to perform ongoing assessments of learners’ retention of knowledge of SOP content for continuous improvement and avoidance of procedural deviations, using the tools already available in your company’s training software.


    Learning Objectives:


    Areas Covered in the Session:


    Who Will Benefit:

    Agenda:

    Day 1 Schedule


    Registration Process – (8:30am – 9:00am)

    Session will begin by – (9:00am)


    8:30-8:59 Registration, Meet & Greet.

    9:00 – 10:00 
    Lecture 1:


    10:00 – 11:00 
    Lecture 2:


    11:00 – 12:00 
    Lecture 3:


    12:00 – 1:00 Lunch


    1:00 – 2:00 
    Lecture 4:


    2:00 – 3:00 
    Lecture 5:


    3:00 – 4:00 
    Lecture 6:


    4:00 – 4:30 
    Lecture 7:

    Day 2 Schedule


    8:30-8:59 Registration, Meet & Greet.

    9:00 – 10:00 
    Lecture 1:


    10:00 – 11:00 
    Lecture 2:


    11:00 – 12:00 
    Lecture 3:


    12:00 – 1:00 Lunch


    1:00 – 2:00 
    Lecture 4:


    2:00 – 3:00 
    Lecture 5:


    3:00 – 4:00 
    Lecture 6:


    4:00 – 4:30 
    Lecture 7:

     

    Speaker

    Michael Esposito

    Principal, TrainReach Consulting, LLC & Life Science Training Institute 

    Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

     

    Location:  Washington, DC Date: October 22nd & 23rd, 2018  and Time: 8:30 AM to 4:30 PM

    Venue:  Courtyard Arlington Crystal City/Reagan National Airport   2899 Jefferson Davis Hwy, Arlington, VA 22202, USA

     

    Price:

    Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

    Sponsorship Program benefits for seminar

    For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

    Contact us today!

    NetZealous LLC DBA GlobalCompliancePanel

    john.robinson@globalcompliancepanel.com  

    Toll free: +1-800-447-9407

    Phone: +1-510-584-9661

     Website: http://www.globalcompliancepanel.com

     

    Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901831SEMINAR?SEO

    Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia/

    Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

    Follow us on Twitter: https://twitter.com/GCPanel

     

     

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    Registration Info

    https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901831SEMINAR?meetings4docs-oct-seo

    Contact the Organizer

    Organized by

    Organized by globalcompliancepanel

    NetZealous LLC DBA GlobalCompliancePanel ,
    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

    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.

    GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

    • Risk Management
    • Regulatory Compliances
    • Corporate Governance
    • Quality Management
    Tel: 800-447-9407
    Email: globalcompliancepanel@gmail.com
    Website: https://www.globalcompliancepanel.com/


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