Skip To The Main Content

PDA 109.1 Container Closure Systems and Integrity Testing

Oct 25 - Oct 27, 2021
Bethesda, MD

  • Education
  • The Americas

left to save

Overview

Please note that this training course will take place in person and has hands-on lab activities. Please read our COVID-19 Facility Access Rules before registering for this training course.

This training course provides insight into the fast-evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. This training course introduces a practical and meaningful methodology to construct package integrity profiles using a risk-based approach and appropriate Container Closure Integrity (CCI) testing methods.

During this training course, participants will have the opportunity to not only observe on-site instrument demonstrations but to also perform various advanced CCI testing techniques to include vacuum decay, electrical conductivity and capacitance, laser-based gas headspace analysis, and mass extraction leak test. In addition, participants can take advantage of the breakout sessions to discuss topics of interest with testing experts from major instrument vendors.

For more options and/or related training courses, please visit the page(s) below.

PDA Parenteral Packaging Training Courses

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Allison L. Dill
Allison L. Dill
Eli Lilly and Company
Lei Li
Lei Li
Eli Lilly and Company

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Develop meaningful design requirements for maximum allowed leakage limit for various product-package types
    2. Describe working principles of various CCI testing techniques, with focus on deterministic methods, such as vacuum decay, electrical conductivity and capacitance (HVLD), laser-based gas headspace analysis, and mass extraction leak test
    3. Develop familiarity with advanced CCI testing technologies via hands-on exercises of testing representative samples
    4. Formulate a comprehensive CCI testing plan throughout product life cycle in support of package integrity verification profile
    5. Apply risk-based approaches to develop a CCI control strategy in which various CCI testing methods are used to inform, verify, and demonstrate package integrity
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in container closure integrity testing for sterile drug manufacturing.

    Departments
    Quality Control, Quality Assurance Operations, Technical Operations, Validation, Packaging

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By September 10, 2021
Member $3,149
Non-member $3,779
Gov't/Health Auth./Academic* $2,449


Regular Registration
Registration Type Price After September 10, 2021
Member $3,499
Non-member $4,199
Gov't/Health Auth./Academic* $2,449


* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially