Subject: Manufacturing

Spray Drying: Operation, Optimization and Design Aspects

This 90-minute accredited online training focuses on the Spray-Drying process and technology, which is present in numerous industries. Even though the training will focus on the fundamentals of Spray-Drying by emphasizing scientific principles that are common to any industry, specific examples will be given for applications in Food, Beverages, Chemicals, Pharmaceuticals, Pulp and Paper, etc.… Continue reading Spray Drying: Operation, Optimization and Design Aspects

Functional Emulsions in the Beverage Industry

This 90-minute, accredited ON DEMAND training course offers a basic understanding of the behavior and properties of emulsions in beverages. It covers principles of emulsion preparation for different types of beverages as well as techniques for analysis of beverage shelf life and emulsion stability. The course will describe specific examples on preparation of emulsions.

Unit Dose Laundry Detergents

an appropriate post-market stability program will also be covered.

IQ, OQ, PQ

Executing Installation, Operational and Performance Qualifications in Support of Process Validations The Installation/Operational/Performance Qualification of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated, and maintained… Continue reading IQ, OQ, PQ

Annual Product Reviews/Product Quality Reviews

Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. The purpose of the annual product quality review course is to educate the participant in the regulatory requirements for the FDA Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as… Continue reading Annual Product Reviews/Product Quality Reviews

Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure… Continue reading Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

The QbD Toolbox: Resources That Help New QbD Programs

If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without a proper understanding of how to establish QbD, your efforts may fail. This 90-minute accredited training course presents methods… Continue reading The QbD Toolbox: Resources That Help New QbD Programs

Qualification and Management of CMOs (Contract Manufacturing Organizations)

Every pharmaceutical company hopes to obtain their desired expectations when it comes to important relationships with their Outsourcing Partners. This intensive course examines the root causes of critical issues that can arise within these relationships which are much broader and deeper than the technical capability to perform a process. This intensive 12-hour, accredited course, examines… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)

Sterilization Professionals Certification

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification

FDA Inspection Readiness Certification

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Inspection Readiness Certification