Skip To The Main Content

Technical Report No. 62: Recommended Practices for Manual Aseptic Processes

Nov 12 - Nov 14, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. Processes using all or partial manual procedures must be evaluated by process verification testing. However, manual operations present unique operational and evaluation challenges not generally encountered with automated operations. For instance, manual aseptic processes rely heavily on individual operator proficiency, which is generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. This and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

Based on PDA’s Technical Report No. 62: Recommended Practices for Manual Aseptic Processes, this training course will provide insight into the technological challenges associated with designing, operating and evaluating manual aseptic processes. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes at their own plants. Participants will also have the opportunity to design, test and evaluate a protocol to perform a manual process simulation.

Ask a Question

Agenda Coming Soon

Want to know when the agenda is posted? Sign up for email updates for the latest information.

Trainers

Cheryl Custard
Cheryl Custard
CBC Training & Consulting
Bio
Cheryl Custard
CBC Training & Consulting

Cheryl Custard is the Principal/Owner at CBC Training & Consulting, an aseptic training and consulting company founded in 2011. She has over 20 years of industry experience in both pharmaceutical/biopharmaceutical aseptic processing, small scale aseptic processing and training & qualification requirements. Cheryl has a Masters of Science Degree from East Stroudsburg University in Pennsylvania, USA, and is an in-kind supporter of various government organizations that audit and support industry aseptic needs. Cheryl is an active member of the PDA and has been a faculty member for the 2-week Aseptic Processing training course, as well as other PDA initiatives, for the last 18 years.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the challenges associated with manual aseptic processing
    2. Describe the elements involved in the design of a manual aseptic process
    3. Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
    4. Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
    5. Design a protocol for the conduct of a process simulation test for manual processing
    6. Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who design, perform and evaluate manual aseptic processes (compounding, filling, packaging and quality operations).

    Departments
    Manufacturing, Quality Assurance, Validation, Manufacturing Technology

    Roles
    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 28, 2019
Member $3,419
Non-member $4,103
Gov't/Health Auth./Academic* $2,279





Regular Registration
Registration Type Price After September 28, 2019
Member $3,799
Non-member $4,559
Gov't/Health Auth./Academic* $2,279





* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Oct 13, 2019, no fee will be charged. After Oct 13, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Oct 13, 2019, a full refund will be given minus a $200 fee. After Oct 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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