Drug In-House Training

OTC cGMP Compliance Review Seminar

EAS presents a one and one-half day intensive program discussing FDA’s current Good Manufacturing Practice requirements and recent inspection findings for human OTC drug products. The course will cover the FDA regulations Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century, Quality Risk-and Science-Based Approaches, Pharmaceutical Development and Pharmaceutical Quality Systems. Participants will gain an understanding of cGMP requirements and FDA’s enforcement of the regulations. FDA issues of concern will be highlighted throughout the seminar with emphasis placed on recent FDA regulatory and administrative actions. FDA investigator observations, as well as problems in dealing with FDA inspections, will be illustrated in the case studies presented.

Marketing and Labeling OTC Drugs and Cosmetics in Compliance with FDA Regulations

OTC Drug and Cosmetic products have come under increased FDA scrutiny. How well do you know current Cosmetic and OTC Drug regulations and regulatory trends? Are your labels in compliance with requirements? How can you keep on top of the latest labeling issues?

Learn cosmetic and OTC drug labeling and compliance from former FDA officials who helped shape current labeling regulations and who understand compliance issues. This hands-on, two-day seminar covers the basics of how cosmetic and OTC drug products are regulated and what is needed to comply with the complex set of labeling rules. The seminar introduces the latest in cosmetic and OTC labeling issues that have gotten attention from FDA and provides answers to your most challenging questions.

Drug GMP Compliance

FDA ensures the quality of pharmaceuticals in the US marketplace through a system of Good Manufacturing Practices (GMPs), a system it takes very seriously. These GMPs provide a standard by which all pharma companies must operate, from handling raw materials, the safety and security of the facilities to testing and validation of equipment and product which together helps to prevent contamination, mix-ups, deviations, failures, and errors.

While drug GMPs are a standard across the industry, understanding how to apply them in each setting is unique as each company is able to determine how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures suitable for their business. EAS Drug GMP Compliance seminar offers an opportunity for a tailored approach, taking these regulations and applying them to your unique manufacturing situation, whether manufacturing an active ingredient or a finished product.

Preparing for FDA Pre-IND Meetings – Steps for Success

Pharma companies with aspirations to study and launch a new product must seek and gain approval from FDA prior to initiating phase 1 study of their Investigational New Drug (IND). The planning and preparations prior to these meetings is immense, as FDA looks for specific criteria indicating due diligence in the design and execution of safety studies, data tracking as well as how results are compiled, mined and presented for FDA consideration.

Learn how to strategize and prioritize the steps to preparations for an FDA Pre-IND meeting from EAS pharma experts who have had successful careers in both industry and FDA.

Pre-FDA Inspection – Preparation, Validation, Qualification

Notification of an FDA inspection creates concern that all processes are adequate to meet stringent standards. Even the best-prepared companies can still have a moment of doubt that their best-laid plans have left out a critical component.

EAS Consulting Group’s Pre-FDA Inspection Seminar – Preparation, Validation, Qualification helps companies prepare for an FDA inspection before FDA walks through the door. Our team of experts, former FDA compliance and inspection officials and industry executives, prepares your in-house experts on the detailed analyses and checks that FDA will be combing through to ensure all applicable requirements are being met or exceeded.