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.

Introduction to GMP for Finished Dose

Lesson Code: PGB-801. 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

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-504. Explains dress codes and why they exist in the finished dose pharmaceutical industry. Examples of the different types of clothing required for the different areas within a pharmaceutical plant are shown.

GMP Goals

Lesson Code: PGB-805. 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-800. Defines Standard Operating Procedures (SOPs), why they are necessary, where they are used, the type of information they typically contain, and how they are controlled.

GMP – Records in Finished Dose Manufacturing

Lesson Code: PGI-801. 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-810. Describes GMP requirements concerning personnel, training, clothing, hygiene and health.

Warehousing

Lesson Code: PGI-620. Introduction to Pharmaceutical warehousing. Covers warehouse functions, GMP in the warehouse and QC status for materials and products.

Cleaning of Equipment

Lesson Code: PGI-730. Different equipment cleaning methods used in the Pharmaceutical Industry.

Sampling

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.

Buildings and Facilities

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

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

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-603. 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-604

GMP Goals for APIs

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-500. What an SOP is, why SOPs must be followed in API plants and what information they should contain.

GMP - Records for APIs

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

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

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

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

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

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

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

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

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

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

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

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

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-500. The responsibilities of executive management in the pharmaceutical industry. Describes 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-700. 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-602. Explains 21 CFR Part 11 in detail and its impact on regulated industries. Particular emphasis on electronic records and signatures (ERES).