GMP Fundamentals Bundle Series - Limited Offer

GMPs

Pre-Approval Inspection Readiness Training Course (T69)

This new training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.

GMP Fundamentals: History

After a history of tragic events that affected public safety, the current Good Manufacturing Practices (GMPs) were developed. GMPs are a set of regulations that uphold the Federal Food, Drug, and Cosmetic Act. It is important to look back at the history of these events, their effect on public health...

GMP Fundamentals: Organization and Personnel

The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the...

GMP Fundamentals: Quality System

To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work...

Cloud Concepts - Cyber Security and Block Chain

This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of...

Aseptic Processing and Annex 1 (T63)

This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)

This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and....

GMP Auditing for Quality Assurance Training Course (G07)

This Auditing for GMP course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.

GMP Fundamentals for the Pharmaceutical Industry (G01)

This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection. They....