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Microbiological Risk Assessment of a Pharmaceutical Manufacturing Process

Oct 19, 2018
North Bethesda, MD

This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes.

  • Education

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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Overview

This course is designed for quality and manufacturing professionals to develop a microbiological risk assessment based on specific pharmaceutical products or processes. Participants will learn to formulate a strategy to proactively look for areas of potential microbial contamination and minimize activities or processes that may cause risk.

Specific activities will include:

  • Reviewing how microbiological quality may be impacted in steps throughout the manufacturing process
  • Identifying risk assessment tools, including the Failure Modes and Affects Analysis (FMEA) approach
  • Creating an example FMEA, incorporating process steps that may have microbial contamination risk
  • Using the FMEA approach to evaluate process and behavior

Who Should Attend

Individuals from the following areas will benefit from attending this course:

  • Manufacturing / Facility Management
  • Product Development
  • Project Management
  • QA/QC
  • Microbiology
  • Validation

Agenda

  • Upon completion of this course, you will be able to:

    • Identify the aspects of pharmaceutical manufacturing which may affect microbiological quality
    • Develop an FMEA, quantifying risk for individual process steps
    • Quantitatively evaluate steps within a process
    • Develop ways to reduce or minimize activities that may increase microbial contamination risk

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    NOTE   Continuing education credits are not available for this event.

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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.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
North Bethesda, MD

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

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Directions

Registration Fees

Regular Price

Standard

Member

On or before September 3, 2018
$1,192

After September 3, 2018
$1,325

Nonmember

On or before September 3, 2018
$1,431

After September 3, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 18, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852 USA

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* 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 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, 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.

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

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

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Tel: +1 (301) 656-5900 ext. 115
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