Pharmaceutical GMP requirements, as specified in 21CFR211, are general and subject to interpretation. This course will focus on the FDA’s current interpretation of the GMP regulation with an in-depth review of the agency’s regulations, guidances, inspection guides, compliance policy guides, compliance programs, proposed rules, publications and policy statements.
S-02. Batch Record Review and Investigations
This course concentrates on the practical applications of GMP and FDA compliance requirements, from the batch record review process to final batch disposition. It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of discrepancies noted from batch production and testing and the decision making process for the final disposition of the batch (i.e., release, reject or rework).
S-04. GMP Compliance Auditing
Although quality and compliance auditing is not specifically required by FDA drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always expected self-audit programs and has criticized companies for failing to conduct such audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations, to identify the critical deficiencies associated with GMP compliance and product quality.
S-05. GMP Compliance and Auditing for Sterile Pharmaceuticals
This course reviews and interprets the current FDA compliance requirements for the production and control of sterile pharmaceuticals, and discusses the practical techniques for conducting an effective and efficient audit.
S-06. GMP Compliance for Quality Control Laboratory Operations
This course reviews the GMP requirements, and their interpretation and application to quality control chemistry and microbiology laboratory operations. The topics include the essential laboratory systems, programs and procedures, the current GMP compliance issues, and the FDA’s expectations for laboratory systems and controls.
S-09. Validation and Qualification Compliance Requirements
his course reviews the GMP compliance requirements for validation and qualification, and the latest FDA interpretations of these GMP requirements and issues. This course also reviews current compliance issues, such as revalidation and requalification, qualification of existing equipment, and provisions for validation/qualification matrixing and bracketing.
S-10. A Review of Cleanrooms and Controlled Environments
Following good contamination control principles is critical to achieving product quality. There are currently over 40,000 standards in the field of contamination control. These standards cover cleanrooms in both the industrial and healthcare marketplace. Understanding of the standards and how they apply to the daily operations of your cleanroom and your process is the focus of this in-house course.