If advanced learning in any PAT topic is desired, we have the seminars!

Understanding the customer business needs is the first rule in the process of finding solutions to become more agile and productive. All the IBS seminars are tailored to the customers needs.

IBS has three levels of PAT & QbD Training. See our .pdf brochures below.

1. PAT Certification is offered with and without labs. (…see more information in PAT Certifications section under PAT Eduction section)
2. The Advanced Hands-on PAT Seminar Series- A continuing education for PAT and QbD enthusiasts
3. Subject Matter Expert in PAT Certification- A two year program for qualifying professionals, with flexible requirements, depending on participant education and experience.(…see more information in Subject Matter Expert section under PAT Eduction section)

The Advanced Hands-on PAT Seminar Series – some examples:

4.0 Multivariate Analysis for Process Control Seminar – One day seminar geared towards industry professionals interested in acquiring greater proficiency in the use of Multivariate Analysis for process improvement and control. The course starts with an overview of MVA methods from a theoretical stand point. Then, it moves towards the application of these tools for process understanding and control. Besides presenting examples, hands-on practice problems will be worked with participants. Participants need to bring a lap-top computer for the hands-on portion of the seminar. Information on installation in the laptops of Umetrics’ Simca-P+ software used for the hands-on portion of the seminar will be provided upon registration.

1.1 NIR & Chemometrics – This hands-on seminar and workshop will provide a fundamental background on near infrared spectroscopy and chemometrics and provide practical advice and hands-on experience. Spectra of blends, granulations, and compressed tablets will be obtained. Case studies will be presented to facilitate implementation at your site. A leading software will be used and installed in laptops for hands-on exercises. Business justification advice will be provided as well as visionary expansion of these technologies into the next level of real-time quality assurance, will be presented.

2.1 Real-Time Process Monitoring Using MVA – The course starts with a basic understanding of multivariate analysis (MVA) and provides an overview of methods and principles for its use in process monitoring with complex and multiple key quality parameters. Statistical process control applications for univariate monitoring & control and the use of six sigma tools to reduce variation and improve quality. Time series analysis, batch statistical process control, and DOE will also be covered. Case studies will be presented to facilitate implementation at your site. Particular uses and needs of attendees, brainstorm with suppliers and consultants- including leading technologies, justification & costs, timetable for implementation and regulatory approach will be subjects for discussion.

The seminar is based on FDA guidance documents that describe the importance of process understanding and the use of manufacturing science to monitor and control product quality.

2.2 MVA in PAT & Model Development Seminar – IBS Caribe, Inc is hosting a world class MVA in PAT & Model Development Seminar, with our top consultants David Gonzalez, PhD, Rodolfo Romañach, PhD, we offer the best seminar in MVA & Model Development possible. The seminar starts with an advanced theory and practice of DoE, Six Sigma and Multivariate analysis as applied to industry needs. This is followed by lectures on how to build robust chemometrics calibration models. This involves the application of PCA and PLS models along with chemometrics tools such as pretreatments, outliers detection, error evaluation, factor selection, model validation and robustness evaluation. Emphasis is made on the topics of qulitative vs quantitative methods, precision and accuracy, cross validation vs validation sets, etc. The seminar finishes with a lecture on regulatory implications and chemomteric models maintenance. Case studies are provided for the different topics.

QbD – Quality by Design. IBS is at the forefront of this regulatory innovation with its developed model: Roadmap to Real-time Release, which is unique in Puerto Rico and abroad. This model strengthens the support of a robust science-based Quality System approach, so that FDA can relax its inspection program and rely on the firm’s own Quality System.

Upon successful completion of this training, participants will have an understanding of the regulatory requirements, the associated quality systems, an overview of the analysis tools for experimentation and application of QbD and the role of QbD in regulatory submissions. The course includes case studies from the Ace Tablets and the Mock P2 submissions (EFPIA 2006).

DoE – Design of Experiments. Special emphasis is provided on using DoE for determining Design Space & Control Strategy, including the generation of surface response and contour plots that show how factors affect Critical Quality Attributes (CQA) of the product. DoE is a tool used in Quality by Design (QbD) to determine which factors affect the CQA, to what extent they affect the CQA, and how the factors interact between one another to affect the CQA. Through an assessment of the number, type, and allowed variability of the factors, DoE enables choosing the appropriate and least time consuming experimental design that will yield the correct assessment of the effect of factors on the CQA. The end goal of DoE is to understand the ranges in which the values of factors that affect the CQA, also known as Critical Process Parameters (CPP), can be changed to produce acceptable values of the CQA.

RBA – Risk Based Assessments. Based on ICH Q9 and using the software tools of Ishikawa Diagrams, FMEA, etc. the participants learn basic or extended tools to identify and mitigate risks to simplify and strengthen the quality system. Case studies are presented for various stages in manufacturing and labs scenarios.