ISPE Online Live Training Courses

ISPE Online Live Training Courses


Turning QbD into a Practical Reality (T43)

Submitted by Anonymous on Mon, 10/18/2021 - 15:30
Date
-

Online Live,
United States

Training Course
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.

Cell & Gene Therapy Course 2b (T68)

Submitted by Anonymous on Wed, 01/19/2022 - 10:30
Date
-
Training Course
This new instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell platforms are presented as the two most common and established therapeutic technologies for Gene Therapy and Cell Therapy, respectively. The purpose of this course it to provide a fundamental understanding of the CMC considerations for C&GT products.

HVAC for Pharma Facilities

Submitted by Anonymous on Tue, 10/19/2021 - 10:30
Date
-

Online Live,
United States

Training Course
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

Oral Solid Dosage Forms (T10)

Submitted by Anonymous on Mon, 10/18/2021 - 15:30
Date
-

Online Live,
United States

Training Course
This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy.

Clean-in-Place (CIP) Fundamentals (T03)

Submitted by Anonymous on Tue, 01/18/2022 - 14:30
Date
-
Training Course
This course will provide a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residue

Pharmaceutical Water Generation (T04)

Submitted by Anonymous on Wed, 01/19/2022 - 11:30
Date
-

Online Live,
United States

Training Course
This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.

Biopharmaceuticals: CMC Aspects Training (T67)

Submitted by Anonymous on Wed, 01/19/2022 - 11:30
Date
-

Online Live,
United States

Training Course
This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization. An emphasis will be placed on using Quality by Design principles to develop, manufacture and guide the product lifecycle. Lastly, we will examine biosimilars and regulatory factors that affect product development and the product lifecycle and drug costs.

Storage Delivery and Qualification of Pharmaceutical Waters

Submitted by Anonymous on Wed, 01/19/2022 - 11:30
Date
-
Training Course
This course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging.

Science and Risk-based C&Q (T40)

Submitted by Anonymous on Mon, 10/18/2021 - 15:30
Date
-
Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.