Skip To The Main Content

Global Regulatory and CGMPs for Sterile Manufacturing

Sep 20, 2019
Washington, DC

  • Education
  • The Americas
Cancelled

Overview

This training course uses a hands-on approach to engage participants in being able to identify, correct and resolve CGMP and global regulatory issues in sterile manufacturing. Case studies, lectures, problem solving targets and risk analysis will be used as part of a toolbox approach to working on and solving actual company CGMP problems in sterile manufacturing.

Ask a Question

Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Frank, S. Kohn
Frank, S. Kohn
FSK Associates
Bio
Frank, S. Kohn
FSK Associates

Dr. Kohn has more than 30 years of experience working in various technical, quality, and management positions. Prior to joining FSK Associates, Frank worked for Wyeth, where he was Director of Manufacturing at the Sanford, N.C. location. He holds graduate degrees in environmental microbiology and operations management. He was on the Publication/Internet committee of ISPE, and was chair of the vaccine interest group for PDA. He has published numerous technical papers, given numerous seminars and lectures. He is a frequent speaker and course leader in the areas of microbiology, technology transfer, cleaning validation and environmental monitoring. For the last eighteen years, Frank has taught courses via The Center for Professional Advancement, PDA, ISPE, etc. in the US and Europe.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify CGMP issues affecting sterile manufacturing
    2. Select the correct solution for poor GMP practices in sterile manufacturing
    3. Evaluate facilities, process and personnel practices for compliance
  • Who Should Attend

    This training course is intended for professionals who are responsible for resolving cGMP issues in sterile drug manufacturing.

    Departments
    Quality Assurance, Quality Control, Manufacturing, Validation

    Roles
    Specialist, Technician, Supervisor, Manager, Scientist

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.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities

    Please visit the hotel’s website for more information.

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

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking

$35 / Daily Self-Parking
$45 / Daily Valet Parking

Other Options

Metro

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train

Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com.

Directions

Registration Fees

Early Registration
Registration Type Price By August 6, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839

Regular Registration
Registration Type Price After August 6, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839

* 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

Related Events

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

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

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

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

PDA Members Save Substantially