2014 Sept Training
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Biotechnology Manufacturing Facility Design Training Course

Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles (T31)

Level: Advanced
ISPE CEUs: 1.5
PMI® PDUs: 2.0
Type: Classroom Training Course
Includes Webinar

Project Management Institute LogoISPE has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI®).

This course has been updated to include content from the Project Management Institute, A Guide to the Project Management Body of Knowledge (PMBOK Guide®, Fifth Edition, Copyright 2013).

Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.

Baseline Guide Cover Image

Immediately apply the course objectives using the complimentary copy of the Biopharmaceutical Manufacturing Facilities Baseline® Guide (Second Edition).

Course Modules

Day 1

  • Introduction: Biomanufacturing design considerations
  • The role of Quality by Design (ICH Q8) in facility design
  • Regulatory expectations - Designing for Compliance
  • QbD in Facility Design
  • Defining the process - CQAs, CPPs, Design Space
  • Equipment considerations

Day 2

  • Facility considerations
  • Utility and Support systems
  • Facility Qualification, Verification, and Process Validation
  • Risk Assessment (ICH Q9)
  • Reference materials: ICH Q8, ICH Q9, ASTM E2500, 2011 FDA Guidance for Process Validation

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

Webinar Learning Objectives:

  • Define controlled processing, primary and secondary segregation, personnel flow, open versus closed systems, and single-product versus multi-product manufacture.
  • Discuss regulatory philosophy, manufacturing operations, process and equipment considerations, process support, facility integration, process controls, automation, and commissioning and qualification of biopharmaceutical manufacturing facilities.
  • Describe additional references available in the Biopharmaceutical Manufacturing Facilities Baseline® Guide.

Take Back to Your Job

  • Discuss facility design concepts related to current Good Manufacturing Practices (cGMPs)
  • Describe the regulatory review process
  • Apply engineering design principles related to biotechnology product manufacturing
  • Understand biotechnology process attributes that impact equipment and facility design
  • Utilize current industry guidance documents that impact facility design
  • Describe impact of critical utilities on facility design
  • Understand project economics and their impact on facility design
  • Discuss current industry trends impacting facility design and construction

Attendance Suggested For

  • Individuals who want to improve their working knowledge of biotechnology manufacturing facility design concepts
  • Professionals who need a focused understanding of the issues a biotechnology manufacturing company must address in order to develop a facility design that meets current regulatory requirements and corporate economic goals
  • Individuals who provide services and/or assistance to biotechnology manufacturing companies to design, construct, validate, and finance facilities

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

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DatesLocationsInstructors 
08 May 2017 -
09 May 2017
San Diego, CA USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
08 April
After
08 April
Member US$1,835 US$2,035
Nonmember US$2,230 US$2,430
Government US$1,010 US$1,120
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
25 Sep 2017 -
26 Sep 2017
Amsterdam, Netherlands Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
26 August
After
26 August
Member €1,735 €1,935
Nonmember €2,080 €2,280
Government €1,145 €1,255
Daily Schedule at a Glance
08.00 – 17.00 Registration Open
09.00 – 17.00 Training Course
10.30 – 11.00 Refreshment Break
12.30 – 13.30 Lunch
15.00 – 15.30 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
23 Oct 2017 -
24 Oct 2017
Boston, MA USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
23 September
After
23 September
Member US$1,835 US$2,035
Nonmember US$2,230 US$2,460
Government US$1,010 US$1,120
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

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