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A Critical Thinking Approach to Improving Aseptic Process Manufacturing

Mar 15, 2019
San Diego, CA

  • Education
  • The Americas
Closed

Overview

This new training course will help you to prepare those responsible for the planning and management of sterile biopharmaceutical product manufacturing with techniques to address today’s aseptic processing challenges and prepare for tomorrow’s new challenges.

During this training course you will learn to select, design, and use quality risk management principle-based tools to recognize where the aseptic process can and should be improved. You will also learn about the most effective technology and procedural improvement strategies that will effectively remediate and resolve regulatory issues. This training course will incorporate case studies, role playing and small group exercises to illustrate, develop, use, and evaluate decision making techniques for various aseptic processing issues, topics, and regulatory actions.

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Agenda

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

Trainers

Hal Baseman
Hal Baseman
ValSource Inc.
Bio
Hal Baseman
ValSource Inc.

Hal Baseman is the Chief Operating Officer and a principal at ValSource Inc. Mr. Baseman has over 40 years of experience in the pharmaceutical, medical device, and biotechnology industry. He has been the Chair of the PDA Board of Directors, the Co-chair of the Science Advisory Board and Co-leader of the Process Validation Interest Group, Co-chair of the EMA Annex 1 comment repose team, Co-leader of the task force on revision of Technical Report No. 22 – Aseptic Process Simulations, Co-leader of the task force for Technical Report No. 44 – Risk Management of Aseptic Processes, Co-leader of the task force for Technical Report No. 60 on Process Validation , Co-chair of the Committee for response to the FDA and the EMA Process Validation Guidance, and the Co-chair of the expert task force for the revision to Aseptic Processing Points to Consider Parts 1 an 2. He is the Co-lead for the Kilmer regulatory collaboration team and contributor on matters related to aseptic processing.

Mr. Baseman holds an MBA from LaSalle University and B.S. Biology from Ursinus College.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain the state of aseptic processing, trends, strengths and weakness, opportunities and threats, regulatory expectations, areas for improvement, and technology opportunities
    2. Evaluate and select manufacturing and process control strategies, new technology and other improvement options
    3. Develop, implement, validate, and transition to operation manufacturing and process control strategies
    4. Demonstrate effective problem-solving techniques, investigate and address process failures and deviations, and respond to regulatory citations
  • Who Should Attend

    This training course is intended for professionals who are involved planning, design, qualification, validation and operation of aseptic processing of sterile biopharmaceuticals. You should have a basic understanding of aseptic processing principles, quality risk management and regulatory citation structure.

    Departments
    Manufacturing, Validation, Quality Assurance, Engineering, Facilities

    Roles
    Supervisor, Manager, Director

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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.

Marriott Marquis San Diego

333 West Harbor Drive
San Diego, CA

  • Accommodations

    Marriott Marquis San Diego
    333 West Harbor Drive
    San Diego, CA USA 92101
    Tel: +1 (619)-234-1500

    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 Marriott Marquis San Diego. The rate is $289* for single or double occupancy. *Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice. Reservations must be secured by Monday, February 11, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Marriott Marquis San Diego at +1 (888) 236-2427. Please make sure to tell the reservationist that you are with the PDA group attending the 2019 PDA Annual 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 to avoid cancellation fees.

  • Amenities

    Read about the amenities offered at the Marriott Marquis San Diego.

How to Get Here

By Air

San Diego International Airport (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel. Taxis are on standby at the San Diego International Airport (SAN), offering service to and from the Marriott Marquis San Diego for an approximate fare of $18 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 15 minutes.

By Car

Directions from San Diego International Airport
Turn left on Harbor Drive. Follow Harbor Drive along waterfront. Hotel will be on right (about 2 miles).

Parking at the Hotel
Self-parking at the Marriott Marquis San Diego is $10 hourly, $35 daily. Valet parking is $50 daily.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price By January 29, 2019
Member $899 $599
Non-member $1,079 $599
Gov't/Health Auth./Academic* $599







Regular Registration
Registration Type Price After January 29, 2019
Member $999 $599
Non-member $1,199 $599
Gov't/Health Auth./Academic* $599







* 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].

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