MSPDA - Educational and Training Opportunities

PDA and the Mountain States Chapter of the PDA present PDA TRI Training!

Three great courses offered in Denver, Colorado by the Parenteral Drug Association Training and Research Institute.
Download as a PDF file, or visit the PDA Website to register or for more infomration on the Denver Course Series.

Risk Management for Aseptic Processing
Date: September 30 - October 1, 2010
Duration: 1.5 Days
Time: September 30: 1:00 p.m. - 4:15 p.m. | October 1: 8:30 a.m. – 4:00 p.m.

Instructor: Harold Baseman, Principal, ValSource, LLC.
Hal Baseman

This interactive course will utilize PDA Technical Report No. 44 Quality Risk Management of Aseptic Processes methodology to identify, assess, manage and use risk to make informed decisions in aseptic processing. Instruction will include background information in quality risk management, regulatory expectations, unique aspects of risk management related to aseptic processing of sterile products, organizational culture, risk assessment methods and examples and the use of risk in process validation.

Member/Nonmembers Standard $1295
Student/Academic $ 780
Government $780

Integration of Risk Management into Quality Systems
September 30 – October 1, 2010
Duration: 1.5 Days
Time: September 30: 1:00 p.m. - 4:15 p.m. | October 1: 8:30 a.m. – 4:00 p.m.
Instructor: Lisa Hornback, Principal Consultant, Hornback Consulting, LLC.

Understand the methods to imbed risk management concepts into elements of your quality systems and utilize current quality data to develop a closed-loop and "living" risk management program. The workshop will include discussion of the primary risk management tools and application of risk management controls to identify, evaluate and mitigate risks. Use of risk management concepts in quality system elements such as design controls, complaints, nonconformance's, use of trending tools and escalation into CAPA will be discussed and will include best practices to integrate these processes to obtain consistent and defendable risk-based decisions.

Member/Nonmembers Standard $1295
Student/Academic $ 780
Government $780

What Every Biotech Startup Needs to Know about CMC Compliance
October 1, 2010
Time: October 1, 2010 : 8:30 a.m. - 4:00 p.m.
Instructor: John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions.

Strengthen your company's CMC program and avoid common pitfalls by gaining vital insight and practical guidance on developing acceptable CMC regulatory compliance strategies for your early clinical stage development (Phase 1 and Phase 2). This course will also give you suggestions on how to organize the CMC responsibilities within a biotech startup and how to develop a cost-effective, risk-managed CMC strategy.

Member/Nonmembers Standard $995
Student/Academic $600
Government $600


Home Officers and Committees Professional Links Join PDA MSPDA Sponsors Photos News & Events Opportunities Employment Education / Training	Educational and Training Opportunities PDA and the Mountain States Chapter of the PDA present PDA TRI Training! Three great courses offered in Denver, Colorado by the Parenteral Drug Association Training and Research Institute. Download as a PDF file, or visit the PDA Website to register or for more infomration on the Denver Course Series. Risk Management for Aseptic Processing Date: September 30 - October 1, 2010 Duration: 1.5 Days Time: September 30: 1:00 p.m. - 4:15 p.m. \| October 1: 8:30 a.m. – 4:00 p.m. Instructor: Harold Baseman, Principal, ValSource, LLC. This interactive course will utilize PDA Technical Report No. 44 Quality Risk Management of Aseptic Processes methodology to identify, assess, manage and use risk to make informed decisions in aseptic processing. Instruction will include background information in quality risk management, regulatory expectations, unique aspects of risk management related to aseptic processing of sterile products, organizational culture, risk assessment methods and examples and the use of risk in process validation. Member/Nonmembers Standard $1295 Student/Academic $ 780 Government $780 Integration of Risk Management into Quality Systems September 30 – October 1, 2010 Duration: 1.5 Days Time: September 30: 1:00 p.m. - 4:15 p.m. \| October 1: 8:30 a.m. – 4:00 p.m. Instructor: Lisa Hornback, Principal Consultant, Hornback Consulting, LLC. Understand the methods to imbed risk management concepts into elements of your quality systems and utilize current quality data to develop a closed-loop and "living" risk management program. The workshop will include discussion of the primary risk management tools and application of risk management controls to identify, evaluate and mitigate risks. Use of risk management concepts in quality system elements such as design controls, complaints, nonconformance's, use of trending tools and escalation into CAPA will be discussed and will include best practices to integrate these processes to obtain consistent and defendable risk-based decisions. Member/Nonmembers Standard $1295 Student/Academic $ 780 Government $780 What Every Biotech Startup Needs to Know about CMC Compliance October 1, 2010 Time: October 1, 2010 : 8:30 a.m. - 4:00 p.m. Instructor: John Geigert, PhD, RAC, President, BioPharmaceutical Quality Solutions. Strengthen your company's CMC program and avoid common pitfalls by gaining vital insight and practical guidance on developing acceptable CMC regulatory compliance strategies for your early clinical stage development (Phase 1 and Phase 2). This course will also give you suggestions on how to organize the CMC responsibilities within a biotech startup and how to develop a cost-effective, risk-managed CMC strategy. Member/Nonmembers Standard $995 Student/Academic $600 Government $600
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