Training and Education

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. Each section of the GMP regulations is reviewed along with the FDA's interpretations of that section. An integral part of this course is the intensive class work to enhance the interpretation and practical application of the GMP requirements.

The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and “how-to” instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA-483 citations and “real-life” experiences.

Although quality and compliance auditing is not specifically required by 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.

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.

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.

This course supplements the “cGMP Interpretation and Application” course with the review of the current FDA requirements and expectations, and the interpretation and application of GMPs (21CFR211) for the production and control of Bulk Pharmaceutical Chemicals (BPCs) and Active Pharmaceutical Ingredients (APIs).

This 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. The topics for review and discussion include process validation, installation and operation qualifications, validation documentation, cleaning validation and computer validation.

Multinational manufacturing supply chains require an understanding of the similarities and differences between the European Union and the United States GMP requirements and expectations. Applying this knowledge becomes critical in designing, implementing, maintaining and auditing systems required to meet both U.S. and EU GMPs. Compliance is a business need.

This workshop begins with a review of the GMP requirements, GMP interpretations, FDA expectations and common GMP compliance problems associated with the product annual review program required by 211.180(e).

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.

The FDA has been increasing their inspection coverage of the pharmaceutical laboratory as a result of significant GMP concerns with laboratory control and operations. This course has been designed to focus on the compliance and quality aspects of microbiological laboratory operations, with emphasis on current regulatory documents and those areas frequently cited by FDA investigators.

This course provides participants with an understanding of the GMP-compliant application of various risk assessment and management techniques. Participants in this course will be part of a team that will actively apply the principles of risk analysis to the start up of a new parenteral facility. With facility blueprints, flows and product specifications in hand, we will use FMEA, HACCP, Fault Tree Analysis, and Environmental Risk techniques to construct and implement a Master Validation Plan for our new product, set up a routine monitoring program and mitigate “excursions” that happen during start up.