ComplianceOnline

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
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(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.
    • 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 02(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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Michael Esposito

Michael Esposito
Principal, TrainReach Consulting, LLC

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 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 Johnson & Johnson Consumer Healthcare 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, product security, and sustainable packaging.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

July 22-23, 2019, Boston, MA
(Registrations till June 11, 2019 - $1299)
(Registrations after June 11, 2019 - $1699)




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before 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 $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location:

Boston, MA
(Venue to be announced shortly)

July 22-23, 2019

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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