Intended Audience - Personnel who will be manufacturing and testing material for human use under U.S. and international GMPs. Suitable as an introduction or refresher course on basic GMPs for wet chemistry processes (drug and IVD) with a focus on clean operations.

This class introduces and reinforces the requirements for manufacturing clinical and licensed materials intended for human use. Special attention is paid to clean and aseptic operations including discussion of cleanroom classes, LAF hoods and isolators. In addition to GMP requirements for documentation, product release, laboratory, and material controls, this class includes a discussion of validation levels appropriate for development and full scale GMP environments. Hand washing, gowning, area prep and behavior are demonstrated and assessed with tough plates to establish and reinforce behaviors necessary for manufacturing material suitable for clinical use. The importance of contemporaneous documentation and immediate reporting of problems for investigation are also stressed.

This class provides attendees with hands-on experience writing procedures and work instructions for regulated environments. Document control systems and regulatory requirements for data recording, and document control are discussed. Exercises performed during the class teach attendees to draft procedures based on user needs and regulatory requirements. Attendees are coached to draft procedures during the class that will be useful to them when they return to the workplace. All attendees will be coached to write a complete SOP during this class.

Intended Audience - Personnel who will be testing incoming raw material, conducting in-process and final product sampling and testing of products for human use under U.S. and international GMPs. Suitable as an introduction or refresher course on basic quality statistics using sampling tables in compliance with GMP, QSR, and ISO13485 and is suitable for biopharma, drug and device manufacturers.

This class provides attendees with information to implement an incoming, in-process, and final product sampling program using the procedures and tables in ANSI ASQ Z.1.4. The class reviews the theory and purpose of attribute sampling and testing, discusses the assumptions necessary for implementing the standard and illustrates - with multiple examples and exercises – the elements of the standard.

Intended Audience – Project managers, IT professionals in the life sciences, management transitioning to life sciences, and personnel with advanced knowledge of one area of GXP who would benefit from an understanding of the other regulated areas of the development process.

This class provides a comprehensive overview of the medical products regulatory approval process and how information systems affect development, animal and human testing, and commercial product quality and compliance. The importance of procedures and documentation of maintenance as well as the meaning and purpose of validated systems are presented and discussed. Focus is on FDA regulations and international quality system requirements that ensure integrity of data for regulatory review.

Intended Audience - Personnel responsible for implementing Good Clinical Practices regulations at the study site, and for sponsor QA and compliance personnel new to GCP compliance and GCP audits. Also appropriate for monitors and sponsors wanting to learn FDA site audit practices.

This class teaches sponsor representatives conducting GCP audits the tools with which to efficiently assess and report site quality. Effective interviewing and reporting skills are practiced during this highly interactive exercise-based session. Data management CRO, clinical packaging, and central laboratory audits are also discussed.

Intended Audience – Personnel and managers conducting non-conformance investigations on products, processes, raw materials and complaints. Includes discussions and examples for those reporting and trending and reporting on internal investigations to upper management under current regulatory requirements.

This class covers the principles and practices of non-conformance and customer complaint reporting and investigation within a quality system. The class starts with a discussion of statistical process control basics and risk scoring which lead to practical exercises designed to ensure that all attendees acquire the skills necessary to document and investigate out of trend and out of spec non-conformances and generate effective Corrective and Preventive Action (CAPA) plans. Investigation techniques and root cause determination are demonstrated using the following: 5 Why; Ishikawa fault tree analysis; and Fishbone diagrams.

Intended Audience – Personnel and management responsible for systems and documentation for manufacturing medical devices for sale outside the U.S. Necessary for anyone who needs to understand quality planning and documentation required for ISO 13485:2008 and CMDR compliance for In-Vitro Diagnostics.

This class discusses elements and successful methods for implementing systems and regulatory documentation required for ISO 13485:2008 and CMDR compliance. Examples and exercises familiarizes attendees with the text of the standards, and provides them with practical skills to document design, manufacture and test processes under regulated quality management system standards. Attendees will learn the 13485 elements including additional requirements under the CMDR. Multiple examples of strategies which conform to international expectations for development and production of products within a documented quality system are presented for discussion.

Intended Audience – Personnel and managers who will be hosting FDA and international regulatory inspections and will be required to present and discuss process development, control and quality systems in working documentation.

This class covers the GMPs for the 21st Century initiative and its primary outputs in the context of an evolving FDA. Pharmaceutical Development, Pharmaceutical Risk Management, and Pharmaceutical Quality Systems are discussed and FDA regulatory trends and observations are described. Exercises include a practice FMECA, creating example development and validation documentation and rationales, and an example Quality Manual for pharmaceutical manufacturing.

Intended Audience – Personnel responsible for internal auditing for quality and compliance under GMP and ISO quality systems.

Supplier auditing is an integral part of determining Quality for incoming QC and the value of contractor certificates of analysis. The class teaches auditing techniques to add value to your supplier quality and GMP auditing functions and increases the efficiency of internal and contract operations. Various scenarios are presented and writing exercise given to ensure that attendees leave the class with skills to conduct and document an effective audit. By the end of this class, attendees will be able to list contractual and regulatory reasons for performing GMP audits, list sources for creating criteria for measuring compliance and quality, and demonstrate effective interviewing and document review techniques. They will also be able to schedule, perform, and document a supplier or internal quality audits and facilitate and assess completion of corrective and preventive action.

Intended Audience – personnel who will be documenting laboratory work and investigations who have scientific skills but who benefit from instruction and practice in prose writing in the scientific IMRAD (Introduction, Methods, Results, Discussion) format.

This class provides a structured environment wherein attendees receive instruction and feedback on exercises designed to improve their writing style and grammar. Students will attend a preliminary exercise-based class focused on report formats and translating an experimental protocol into a report of results. The second day of class includes one-on-one reviews of in-process reports to ensure that all attendees are meeting class requirements and can successfully complete assigned exercises. Attendees are strongly advised to bring work to the classes that they will be required to perform as part of their daily jobs to maximize return on investment for the training. (Note: Class size is limited to 15 students).