Lesson Code: PGB-900. Introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant.
Lesson Code: PGB-1101. What GMP is, why it is important for safe guarding the end user, and the laws that govern it.
Lesson Code: PGB-902. Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in inspections.
Lesson Code: PGB-503. How finished dose products can be contaminated during production and how to minimize contamination through the use of PPE and good sanitation habits.
Lesson Code: PGB-1204. This e-Lesson is aimed at finished dose manufacturing personnel who require an overview of dress codes, why they are needed, and how they are used in different areas of a finished dose facility.
Lesson Code: PGI-1100. The e-Lesson is aimed at personnel in finished dose manufacturing who use SOPs to ensure that operations are consistently performed correctly and in accordance with relevant GMP regulations.
Lesson Code: PGI-1101. How to complete records required for Finished Dose manufacture. Records include records of materials, production records, equipment records, laboratory records, production review and distribution records.
Lesson Code: PGI-1110. Describes GMP requirements concerning personnel, training, clothing, hygiene and health.
Lesson Code: PGI-620. Introduction to Pharmaceutical warehousing. Covers warehouse functions, GMP in the warehouse and QC status for materials and products.
Lesson Code: PGI-1230. Different equipment cleaning methods used in the Pharmaceutical and Biologics Industry.
Lesson Code: PGI-840. The different types of sampling methods found in the Pharmaceutical Industry. Also includes rules that should be followed when sampling materials.
Lesson Code: BGB-501. What GMP is in terms of the API industry, why it is important for safe guarding the end user, and the laws that govern it?
Lesson Code: BGB-502. Who regulates the API industry, how new drugs are approved, types of regulatory inspections and inspection outcomes, and the role of employees in inspections.
Lesson Code: BGB-1203. How API products can be contaminated during production and how to minimize contamination through the use of PPE and good hygiene habits.
Lesson Code: BGB-1204 This e-Lesson is aimed at personnel in API manufacturing who require an overview of dress codes, why they are so important in the API industry, and the different types of PPE typically required for different tasks.
Lesson Code: BGI-500. What an SOP is, why SOPs must be followed in API plants and what information they should contain.
Lesson Code: BGI-501. How to complete records required for API manufacture. Records include batch production records (BPR), Master production records, equipment records, records of materials and laboratory sample records.
Lesson Code: MGB-500. Introduces the Medical Device Industry and the typical departments found in a medical device plant.
Lesson Code: MGB-501. What GMP is, why it is important for safe guarding the end user, and the laws that govern it.
Lesson Code: MGB-502. Who regulates the Medical Device Industry, what the role of the FDA is for medical devices, how a regulatory inspection is carried out, and the role of each employee in an inspection.
Lesson Code: MGB-503. The importance of personal hygiene in a medical device plant and the implications of poor hygiene practices for the product and the employee.
Lesson Code: MGB-504. Explains dress codes and why they are so important in the Medical Device Industry. Examples of the different types of clothing required for different tasks are given.
Lesson Code: MGI-500. What an SOP is, why SOPs must be followed in Medical Device Plants and what information they should contain.
Lesson Code: MGI-501. Outlines the fundamental rules for completing records and discusses the requirements for several of the most frequently encountered records. Records include Device History Records, Equipment Records and Acceptance Activity Records.
Lesson Code: NGI-800. Defines Standard Operating Procedures (SOPs), why they are essential in the manufacture of nutraceuticals, where they are used, the type of information they typically contain, and how they are controlled.
Lesson Code: NGI-801. Defines records, why they are essential in the manufacture of nutraceuticals, how and where they are used, the type of information they typically contain, and the rules for how they should be completed.
Lesson Code: RGM-1200. Overview of the regulatory responsibilities of executive management in the pharmaceutical manufacturing industry. This e-Lesson explains FDA and legal requirements and the corporate and personal consequences of non-compliance.
Lesson Code: GVC-1200. Explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries.
Lesson Code: CSV-901. Explains the fundamentals of computerized systems validation and the validation process as recommended in the GAMP® guideline. Also introduces the FDA's 21 CFR Part 11 ruling on electronic records and signatures.