Packaging and Labeling in Pharmaceutical Production: 2-Day In-Person Seminar

By: Michael Esposito, Principal, TrainReach Consulting, LLC
Coming soon.. Please contact customer care for new schedule

We need the below information to serve you better

Course Description:

Seminar to help you understand compliant packaging and labeling process in the larger product development from conception of a product to its realization and distribution. Get equipped to reduce cycle time, avoid costly errors and delays, or product recalls.

Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.

Packaging and Labeling activities are crucial. They should comply with regulatory agency requirements. They form a bridge between the conception of a product and its realization and distribution. Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success.

Learning Objectives:

  • Articulate Packaging and Labeling’s role in product development
  • Ensure adherence to regulatory agency requirements
  • Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance
  • Work effectively with contract manufacturers or packagers
  • Manage labeling in foreign languages
  • Avoid unnecessary production costs, back orders and recalls, especially during product launches

Areas Covered:

  • Regulatory Agency Requirements
  • SOPs and Change Control considerations related to packaging
  • Packaging and Labeling Interactions
  • Creation of the Package
  • Codes
  • Packaging Errors
  • Labeling Errors
  • Supply Chain Issues
  • Special Considerations (e.g. product launches, clinical vs. commercial packaging)
  • Knowledge assessment

Who will Benefit:

Pharmaceutical industry, particularly those areas that develop packaging for the manufacturing of pharmaceutical products (Product Development, Production Planning, Manufacturing, Quality Assurance)

This course will be of benefit to anyone who is a stakeholder in product launches, revisions to pharmaceutical labeling and packaging, or timely delivery of product, including

  • Marketing
  • Project Management
  • Operations
  • Regulatory Affairs
  • Labeling and Packaging
  • Quality Assurance
  • Production Control
  • Packaging Technology
  • Labeling Coordination
  • Package Engineers
  • Packaging Operations
  • Sales and Marketing
  • Quality Assurance

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 9:00 AM -10:00 AM:
    • Seminar objectives review, expectations and scope.
    • nterview attendees re their specific responsibilities and needs
    • Agreement on focus
  • 10:00 AM -11:00 AM:
    • Regulatory requirements for packaging and labeling: FDA packaging regulations, FDA labeling regulations, FDA packaging regulatory requirements, FDA labeling regulatory requirements
    • SOPs and Change Control considerations related to packaging: What commitments you make when you put your process in writing
    • Consequences of noncompliance
  • 11:00 AM -12:00 PM:
    • Packaging and Labeling Interactions
    • Packaging and Labeling workflows
    • Review/knowledge check
  • 12:00 PM -01:00 PM: Lunch
  • 01:00 PM -02:00 PM:
    • Creation of the Package: bill of materials, packaging component specifications, CAD drawings, materials, dimensions, folds, quiet areas, packaging line trials
    • Unique identifiers (package, component numbers)
  • 02:00 PM -03:00 PM:
    • Codes - introduction
    • Customer codes - types, positioning on components
    • Company codes - types, positioning on components
  • 03:00 PM -04:00 PM:
    • Verification of codes on packaging equipment
    • Product security considerations
  • 04:00 PM -04:30 PM: Knowledge check for day
  • Day Two (8:30 AM – 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM -10:00 AM:
    • Seminar objectives review, expectations and scope
    • Review of Day 1 topics, feedback and conclusions
  • 10:00 AM -11:00 AM:
    • Labeling creation process
    • Printed component types and considerations
    • Serialization requirements
    • Interaction with printers
  • 11:00 AM -12:00 PM:
    • Effects of Packaging and Labeling on:
      • Production
      • Warehousing and distribution
      • Consumer use of product
    • Knowledge check
  • 12:00 PM -01:00 PM: Lunch
  • 01:00 PM -02:00 PM:
    • Packaging and Labeling errors
    • Level of gravity of error depending on when it occurs
    • Packaging and Labeling review of errors
  • 02:00 PM -03:00 PM:
    • Supply Chain issues
    • Product launches
    • Clinical vs. commercial packaging
    • Role play for a product launch
  • 03:00 PM -04:00 PM:
    • Course review: overall impact of Packaging and Labeling in pharmaceutical production
    • Questions and feedback
  • 04:00 PM -04:30 PM: Knowledge assessment
  • Meet Your Instructor

    Marina Malikova
    Michael Esposito
    Principal, TrainReach Consulting, LLC

    Michael Esposito has 30 years’ experience in the pharmaceutical industry and 13 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 work plan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

    Register Online

    Register Online

    $0
    Get the Invitation
    Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
    Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

    Register by Wire Transfer

    If you wish to pay by wire transfer: Please call us at
    Toll Free +1-1-888-771-6965

    Download Registration Form

    Yes, I want to attend "Packaging and Labeling in Pharmaceutical Production: 2-Day In-Person Seminar"
    Click here to Download Registration Form
    If you are paying by check:
    Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
    2479 East Bayshore Road, Suite 260
    Palo Alto, CA 94303
    USA

    Terms & Conditions to register for the Seminar/Conference/Event

    Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

    Payment:

    Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

    Cancellations and Substitutions:

    Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

    On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars event and a credit note will be issued.

    Substitutions may be made at any time. No-shows will be charged the full amount.

    We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

    In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

    Attendance confirmation and Documents to carry to the seminar venue:

    After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

    Conference photograph / video:

    By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

    Media Partners

    If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
    Media Partner Benefits
    • Logo and company data on the event website.
    • Logo on the conference material distributed during the conference.
    • Media Partner’s brochure distributed along with conference material.
    • Logo on all the mailings before and after the event.
    • 10% discount to media partner's subscribers.
    Media Partner to do
    • Banner (min 728x90 or 468x60) on the Media Partner website.
    • Insertion of the event in the event calendar, both printed and/or online.
    • Announcement article of the conference on the Magazine and/or Website.
    • Dedicated email blast to all subscribers of Media Partner.
    • Article on the Magazine and/or Website after the conference.

    Local Attractions of San Diego, CA

    San Diego Cabrillo National Monument
    The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.

    Sea Creatures at Birch Aquarium
    Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.

    Legoland
    Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.


    San Diego Zoo Safari Park
    The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

    Coronado Island
    Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

    Balboa Park
    Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.