GMP, Compliance, Regulatory


Pharmaceutical GMP - Basics

Overview of Pharmaceutical Manufacturing

Lesson Code: PGB-900. Introduces the Pharmaceutical Industry, what it manufactures, and the typical departments found in a pharmaceutical plant.

GMP for Finished Dose

Lesson Code: PGB-1101. What GMP is, why it is important for safe guarding the end user, and the laws that govern it.

Regulation of the Pharmaceutical Industry

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.

Finished Dose Contamination Prevention

(HTML-5 rebuild & remaster in progress - available soon) 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.

Dress Codes for Finished Dose Manufacture

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.

GMP Goals

Lesson Code: PGB-1105. Describes the GMP responsibilities of employers and employees and the importance of procedures and records.

Pharmaceutical GMP - Intermediate

GMP - SOPs in Finished Dose Manufacturing

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.

GMP – Records in Finished Dose Manufacturing

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.

Personnel and Training

Lesson Code: PGI-1110. Describes GMP requirements concerning personnel, training, clothing, hygiene and health.

Warehousing

Lesson Code: PGI-1220. This e-Lesson is aimed at personnel who require an overview of warehousing principles and practices in pharmaceutical and biologics facilities.

Cleaning of Equipment

Lesson Code: PGI-1230. Different equipment cleaning methods used in the Pharmaceutical and Biologics Industry.

Sampling

Lesson Code: PGI-1240. This e-Lesson is aimed at personnel who perform sampling tasks on raw materials, manufactured samples, or final products in pharmaceutical manufacturing facilities.

Buildings and Facilities

(HTML-5 rebuild & remaster in progress - available soon) Lesson Code: PGI-690. The GMP design requirements for a manufacturing facility. This includes the product flow, environmental controls, cleaning and sanitization.

API Manufacturing GMP - Basics

Introduction to GMP for APIs

(Back Catalog) 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?

Regulatory Agencies

(Back Catalog) 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.

API Contamination Prevention

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.

Dress Codes for APIs

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.

GMP Goals for APIs

(Back Catalog) Lesson Code: BGB-505. GMP from the point of view of the API company, the employee, and the consumer. Also, the implications of non-compliance for each.

API Manufacturing GMP - Intermediate

GMP - SOPs for APIs

Lesson Code: BGI-1200. This e-Lesson is aimed at personnel in API manufacturing who use SOPs to ensure that operations are consistently performed correctly and in accordance with relevant GMP regulations.

GMP - Records for APIs

(HTML-5 rebuild & remaster in progress - available soon) 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.

Labeling in API Plants

(Back Catalog) Lesson Code: BGI-580. The importance of accurate labeling in an API plant. What must be contained on a label, along with label distribution and reconciliation.

Medical Device GMP - Basics

Introduction to Medical Devices

(Back Catalog) Lesson Code: MGB-500. Introduces the Medical Device Industry and the typical departments found in a medical device plant.

Introduction to GMP for Medical Devices

(Back Catalog) Lesson Code: MGB-501. What GMP is, why it is important for safe guarding the end user, and the laws that govern it.

Regulatory Agencies for Medical Devices

(Back Catalog) 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.

Hygiene for Medical Devices

(Back Catalog) 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.

Dress Codes for Medical Devices

(Back Catalog) 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.

GMP Goals for Medical Devices

(Back Catalog) Lesson Code: MGB-505. GMP from the point of view of the medical device company, the employee, and the consumer. Also, the implications of non-compliance for each.

Medical Device GMP - Intermediate

GMP - SOPs for Medical Devices

(Back Catalog) Lesson Code: MGI-500. What an SOP is, why SOPs must be followed in Medical Device Plants and what information they should contain.

GMP - Records for Medical Devices

(Back Catalog) 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.

Medical Devices - Personnel & Training

(Back Catalog) Lesson Code: MGI-510. The qualifications and training that medical device employees need in order to comply with GMP. Who must be trained and why.

Nutraceutical GMP

GMP - SOPs in Nutraceutical Manufacturing

(Back Catalog) 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.

GMP – Records in Nutraceutical Manufacturing

(Back Catalog) 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.

Regulatory GMP for Management

Executive Responsibility in Pharmaceutical Manufacturing

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.

Computer Use and Validation

IT Use in Regulated Industries

Lesson Code: GVC-1200. Explains the basics of Information Technology and Good Computer Practice and looks at how IT is used in regulated industries.

GxP Computerized Systems Validation

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.

Introduction to 21 CFR Part 11

Lesson Code: GVC-1202. This e-Lesson is aimed at personnel who require an overview of the 21 CFR Part 11 regulation and its associated terminology, how it affects regulated industries, and the criteria for complying with its requirements.