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.
At this Seminar You Will:
- Learn the requirements of the regulations.
- Gain an understanding of how FDA is enforcing the regulations.
- Receive detailed practical guidance on how to apply these requirements.
- Be given an opportunity to demonstrate your understanding of GMPs in case studies
- Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) at the end of an FDA inspection.
Finally, there will be a discussion of responding to FDA 483s and Warning Letters.
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.
At the Seminar, You Will
- Understand OTC and Cosmetic compliance and labeling requirements from experts who helped to develop and implement the current regulations and have reviewed hundreds of regulatory issues for the industry.
- Learn about Cosmeceuticals, what’s permitted, and how to avoid trouble.
- Understand the OTC Monographs and how they can be used to your advantage in marketing your product.
- Learn about hot issues that have triggered recent FDA warning letters.
- Have your specific issues addressed and discussed in a casual, interactive learning environment.
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.
In the EAS Course you will:
- Understand each component within pharmaceutical GMPs and how they can be implemented in your business
- Have an in-depth discussion on how to validate results and calibrate equipment to ensure quality is maintained
- Discuss how to capture and track adverse events reporting
- Develop a checklist to prepare for FDA inspections and 483 Warning Letters
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.
In this course you will:
- Learn the structure and goals of pre-IND meetings
- Prepare your company’s checklist for required documentation
- Anticipate FDA’s questions for better preparation
- Understand “best practices” for navigating and communicating with FDA throughout the Pre-IND process
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.
In this seminar you will:
- Understand what to expect in an FDA inspection
- Take a close look at your processes, systems and procedures to ensure you are meeting FDA requirements and developing an improvement plan in advance of the inspection for those items that do not
- Understand the what’s and how’s of qualification and how to ensure results are appropriately validated
- Understand how best to collect and track adverse events reporting
- Set-up internal documentation structures so that FDA may easily access required information
- Discuss on 483 Warning Letters and required responses