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Oral Solid Dosage: New Guidance You Can Use Right Now
Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides
22-24 February
HVAC for Pharmaceutical Facilities (T14)
24-25 February
Practical Application of Computerized Systems Compliance: Applying the GAMP®5
Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (T11)
Oral Solid Dosage: New Guidance You Can Use Right Now
Examine and extract critical perspectives from warning letters and apply the new industry guidance to the benefit of your company. The session will cover key topics including: risk assessment, adulteration, compliance-focused processes, as well as other key topics vital for multi-product production and development. This session will feature the entirely new, ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms, which has been reviewed by the FDA. Issues identified in warning letters will be used as the basis for problem-solving workshops and discussions with subject matter experts. An FDA speaker has been invited and the two-day seminar will be lead by members of the Guide Writing Team.
An OSD Guide copy will be provided as part of seminar registration.
Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides Good Engineering Practice (GEP), as a broad collection of engineering and risk management activities, is becoming recognized in the pharmaceutical and life sciences industries as an essential foundation upon which efficient operations and regulated activities are built. The ISPE Good Practice Guide: Good Engineering Practice provides definitions, examples, and execution guidance for lifecycle engineering management applications. Take advantage of interactive workshops and the expertise of practitioners as attendees and leaders solve real-life challenges. This two-day seminar aids the attendees with hands-on applications to demonstrate how each of these Guides will help you in your work.The ISPE Good Practice Guide: Maintenance provides definitions, examples, and guidance for development and execution of effective, comprehensive maintenance programs.
2010 Tampa Conference Sessions
22-23 February
* Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World (E01)
* Inspection Readiness Workshop: From Site Preparation to Successful Execution (E02)
* OSD - New Guidance You Can Use Right Now (E03)
* Lean Project Delivery: Leveraging New ISPE Guides on Commissioning and Qualification and GAMP® 5 (E04)
24-25 February
* Managing the Risks and Challenges of Syringe Processing (E05)
* Containment Technology Forum: Basics and Beyond (E06)
* Technology Transfer: Focus on the Business Process and Practical Execution (E07)
* Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides (E08)
Early Bird Discounts
Register on or before 25 January to take advantage of early bird discounts.
Individual Seminar Registration Fees
(Discounts cannot be combined) On or Before 25 January Regular/Onsite
(After 25 January)
First Two-day Seminar Fee Current Member: US$1,050 Current Member: US$1,350
Additional Two-day Seminar Fee
(save 20%) Current Member: US$840 Current Member: US$1,080
Individual Training Course Registration Fees On or Before 25 January Regular/Onsite
(After 25 January)
T14 - HVAC for Pharmaceutical Facilities - Monday, Tuesday, and Wednesday Current Member: $1,985 Current Member: $2,285
T11 - Practical Application of Computerized Systems Compliance: Applying the GAMP®5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems - Wednesday and Thursday Current Member: $1,610 Current Member: $1,910
Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides
22-24 February
HVAC for Pharmaceutical Facilities (T14)
24-25 February
Practical Application of Computerized Systems Compliance: Applying the GAMP®5
Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (T11)
Oral Solid Dosage: New Guidance You Can Use Right Now
Examine and extract critical perspectives from warning letters and apply the new industry guidance to the benefit of your company. The session will cover key topics including: risk assessment, adulteration, compliance-focused processes, as well as other key topics vital for multi-product production and development. This session will feature the entirely new, ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms, which has been reviewed by the FDA. Issues identified in warning letters will be used as the basis for problem-solving workshops and discussions with subject matter experts. An FDA speaker has been invited and the two-day seminar will be lead by members of the Guide Writing Team.
An OSD Guide copy will be provided as part of seminar registration.
Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides Good Engineering Practice (GEP), as a broad collection of engineering and risk management activities, is becoming recognized in the pharmaceutical and life sciences industries as an essential foundation upon which efficient operations and regulated activities are built. The ISPE Good Practice Guide: Good Engineering Practice provides definitions, examples, and execution guidance for lifecycle engineering management applications. Take advantage of interactive workshops and the expertise of practitioners as attendees and leaders solve real-life challenges. This two-day seminar aids the attendees with hands-on applications to demonstrate how each of these Guides will help you in your work.The ISPE Good Practice Guide: Maintenance provides definitions, examples, and guidance for development and execution of effective, comprehensive maintenance programs.
2010 Tampa Conference Sessions
22-23 February
* Aseptic Processing of Sterile Products: Innovations, Regulatory Guidance and Compliance in a Practical World (E01)
* Inspection Readiness Workshop: From Site Preparation to Successful Execution (E02)
* OSD - New Guidance You Can Use Right Now (E03)
* Lean Project Delivery: Leveraging New ISPE Guides on Commissioning and Qualification and GAMP® 5 (E04)
24-25 February
* Managing the Risks and Challenges of Syringe Processing (E05)
* Containment Technology Forum: Basics and Beyond (E06)
* Technology Transfer: Focus on the Business Process and Practical Execution (E07)
* Beyond Book-learning: Practical Application of Good Engineering Practice and Maintenance Guides (E08)
Early Bird Discounts
Register on or before 25 January to take advantage of early bird discounts.
Individual Seminar Registration Fees
(Discounts cannot be combined) On or Before 25 January Regular/Onsite
(After 25 January)
First Two-day Seminar Fee Current Member: US$1,050 Current Member: US$1,350
Additional Two-day Seminar Fee
(save 20%) Current Member: US$840 Current Member: US$1,080
Individual Training Course Registration Fees On or Before 25 January Regular/Onsite
(After 25 January)
T14 - HVAC for Pharmaceutical Facilities - Monday, Tuesday, and Wednesday Current Member: $1,985 Current Member: $2,285
T11 - Practical Application of Computerized Systems Compliance: Applying the GAMP®5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems - Wednesday and Thursday Current Member: $1,610 Current Member: $1,910
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