Training Courses, Classes, Seminars and Webinars

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures.

Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis – Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. But mandatory HIPAA Compliance Audits conducted by the Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), found 94% of Covered Entities failed the Risk Management Audit and 87% failed the Risk Analysis Audit. And every audited Covered Entity knew well in advance that it was on the short list to be audited, had completed pre-audit questionnaires and knew the exact questions it would be asked and documentation to be provided (audit protocols).

This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs.

Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you understand, develop, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorporate Design Controls into your product development process to help streamline development and ensure Quality and compliance.

This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA. The seminar will discuss in detail the: Types of inspections done by US FDA, EMA and PMDA Typical Audit Agenda that can be expected by each Authority Scope of Audits.........how many auditors, how many days When audits will likely occur The expectation differences between inspections of API and Finished Product facilities What areas of GMP become a focus by region

We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: 21 CFR Part 11 and Computer Validation: Why so many citations? Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11 Data Integrity vs Computer Systems Validation Overview and Key Requirements of Part 11 & CSV How to use a Risk Based Assessment to reduce work while still achieving Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.

This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality and compliance as well as optimizing the cost of quality. This seminar will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing

This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback.

This course will describe the development of job position curricula in the pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula. A Pharma curriculum is the sum total of all the courses that an employee in a specific position requires, and is composed of smaller groups of courses called modules. A curriculum typically will include a "core curriculum" (usually several modules) with all the required courses for all employees involved in GMP functions, a "job-specific" group of courses for the position, modules reflecting further subdivision of responsibilities within individual positions, roles in validated computer systems such as investigations, and roles in applicable hard-copy review processes.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform, and are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing. Pharmaceutical employees often do not realize that by putting their processes in writing, they are making commitments to regulatory agencies. To achieve the goal of an SOP that has adequate but not excessive detail, the course will define the parameters of an effective SOP and provide a solid foundation that will have a positive impact on training and job performance. Conversely, the negative impact of poorly written procedures on production and compliance will also be explored.

This 2-Day seminar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Why Should You Attend? By attending, you will take advantage of a great opportunity to advance as a manager to the next level! Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again! We'll take you through peer discussions addressing leading and managing, integrating finance and quality, managing your time effectively, managing performance and managing up.

The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice owner; meaning that is both general as well as highly specialized and unique to each healthcare practice. As this 2-day training commences, the four R's are introduced and explained in general terms, along with a discussion of how this highly successful business development process came into existence.

Customer satisfaction plays a significant role in measuring a product's postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control your post market problems. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).

In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive. Also, managing risks is critical to reducing exposure from breaches or cybercrime.