Two Days of Dynamic Training

Take advantage of the early registration discount for each course!

Join us after the 2018 ISPE Annual Meeting & Expo for an in-depth education experience on the following topics:

Cleaning Validation Principles
8–9 November 2018

This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication. Additional content includes elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes and establishment of scientific rationales acceptable to regulatory inspectors. For mature cleaning validation programs, concepts such as understanding process control, capability, learning to effectively self-audit a cleaning validation program and documentation will be essential takeaways.

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Rebecca Brewer photo Instructor:
Rebecca Brewer
Vice President Strategic Practices
Quality Executive Partners Inc

Rebecca Brewer has more than 29 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries.  She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013.


Facility Project Management in the Regulated Pharmaceutical Environment
8–9 November 2018

This interactive course provides more than the usual project basics. It develops the concept of project lifecycle from initiation through delivery of business benefits, along with tools to manage all project resources. It is specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of "good practice" project management. Trends in regulatory compliance, environmental, health and safety legislations, project delivery methodologies, and product speed-to-market expectations all impact how pharmaceutical facility projects are managed. Each course module introduces key project management concepts and tools as well as methodologies that specifically support successful project delivery.

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Instructor:
Robert Perry
Facility Project Management in the
Regulated Pharmaceutical Environment

Robert Perry is a senior project professional with over thirty years of facilities project and construction management experience in the commercial, industrial and municipal markets. He has extensive experience in program and project management in the life sciences and microelectronics industries


 

Risk-Based Verification of Facilities, Systems and Equipment Workshop
8–9 November 2018

This interactive course will provide tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program. Through interactive workshops participants will more fully understand and apply the principles of ASTM E2500-07 and ICH documents (Q8(R2), Q9, and Q10) to the documented verification of pharmaceutical and biopharmaceutical facilities, systems and equipment that are suitable for their intended purpose. Templates will be developed to facilitate the translation of the scientific knowledge about the product and process into documented specification, design, and verification of facilities, systems, and equipment.

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Instructor:
Daniel Franklin
Manager, Compliance Services,
CIRM, CxA

Daniel Franklin has over 30 years of project delivery and operations support experience. Graduated from Lewis University with a Bachelor of Science degree in Aviation Maintenance Management. Franklin has also earned an MBA degree from National University and a number of industry certifications & licenses.


Quality Management Systems: Agile Approach for Product Realization & Lifecycle Management
8–9 November 2018

The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach.

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Instructor:
Jean Poulos
Principal Consultant
Lachman Consultant Services, Inc.

Bruce S. Davis

Instructor:
Bruce S. Davis
Principal
Global Consulting

Bruce Davis is a professional engineer, and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and reducing Human Error. He is an Associate to NSF-DBA, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, and this extended to provision of sterile facilities.