Palo Alto, California
Upcoming Events in Palo Alto California
April
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GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit and how to avoid them
- This GCP training will guide you through key component identification of a good GCP audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, data sampling and audit findings assessments. Why Should You Attend: All CRO’s, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for an audit. The main principle is to follow exactly the signed and approved (IRB + PI) protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trial process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. All sites conducting Clinical Research should know how to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. Attending this webinar is a good step toward learning the FDA processes and why a knowledgeable PI is so important. The components of a quality in-house monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections. It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. This webinar will review FDA inspection program details and how to ensure your site is prepared for an inspection. It will help you to avoid the common GCP mistakes and enhance the overall audit experience. Areas Covered in the Webinar: -What does the FDA look at when auditing/inspecting a study? -The regulatory requirements for the BIMO program -Studies targeted for auditing and what does the Inspector/Auditor look for? -What are the common GCP mistakes sites make? -The nature of adequate oversight of all staff and non-staff -The importance of protocol knowledge in preventing errors -How do sites prepare for an audit / inspection -What happens after an inspection / audit is done? Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the pharmaceutical, biotechnology, and CRO industry conducting clinical trials including: -Sponsor Senior Management -Project Managers -CRA Managers -QA/Compliance Personnel -Principal Investigators and Sub Investigators -Clinical Research Scientists (PKs, Biostatisticians) Safety Nurses -Clinical Research Associates (CRAs) and Coordinators (CRCs) -Recruiting Staff -QA / QC Auditors and Staff -Clinical Research Data Managers Instructor Profile: Charles H. Pierce, MD, PhD, FCP, CPI has 20+ years’ experience in the Clinical Research field. He now brings the message (via publications, webinars, lectures and seminars) of risk management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies. Address: Online Event , Palo Alto, California |
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Leveraging and Managing Big Data for GRC
- This webinar will focus on the concept of big data and the associated GRC challenges and opportunities. Attendees will learn how GRC related policies, procedures and infrastructure are used to manage big data. Why Should You Attend: New business paradigms, markets, product pipelines, regulations and data flowing in with increased velocity, variety and volume are challenging firms to re-evaluate existing policies, procedures, controls and even underlying data models and infrastructure. This webinar will provide insights into how GRC related policies, procedures and infrastructure are evolving to leverage as well manage big data. It will provide insights into the main drivers for big data adoption, the evolution of big data analysis frameworks for Enterprise Risk Management and the need for harmonization of GRC practices across the enterprise. Learning Objectives: -Understanding some of the risk and compliance challenges and opportunities with big data -Building a more agile, proactive approach to enterprise-wide GRC with actionable intelligence -Developing a strategic roadmap for big-data led GRC initiatives -Recommendations for effective data governance and data life-cycle management Areas Covered in the Webinar: -The state of big data and its relevance to GRC -Deriving actionable intelligence from big data – using big data to see the big picture – capturing, collecting and correlating data -Insights into some of the GRC challenges facing firms running big data programs and initiatives -Big data and associated data governance challenges -Protecting sensitive data in the ecosystem -Recommendations for building a GRC roadmap for big data adoption Who Will Benefit: -Firms interested in building a risk and data governance roadmap for big data -Risk Management Professionals -Governance, Risk, Compliance (GRC) staff -CIOs, CISOs, CROs -Data Czars, Data Stewards, Data Managers -Regulatory Compliance Managers and Associates Instructor Profile: Gita Seshadri, is a risk practitioner and thought leader in the risk and compliance arena across Banking and Capital Markets. She has built and led Risk and Compliance practices for several firms, conducted large scale risk assessments and has participated in several product engineering initiatives for rolling out risk and data management frameworks. Address: 2600 E. Bayshore Road , Palo Alto, California |
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AS9103 Variation Management of Key Characteristics: Aerospace QMS Within the AS Series QMS Requirements
- This webinar on aerospace Quality Management Systems (QMS) will discuss the core requirements for controlling variation in processes as required in AS9103 Variation Management of Key Characteristics. Why Should You Attend: The Aerospace Quality Management Systems in accordance with ISO/AS9100, 9110, 9120 IAQG Requirements drive several additional requirements that are generally flowed down via customer expectations within their contracts, purchase orders or embedded within their specifications. This 90-minute training session is designed to show you what the requirements are, how to invoke the requirements within your Quality Management System and to allow you a better understanding of the methodologies the standard is looking for. Customer expectations and specific customer requirements will be much easier to understand and include once the solid understanding of the AS9103 standard is presented to you. This webinar will provide valuable assistance in: -Determining the basic requirements of AS9103 -What the OEM’s are looking for and addresses some unique requirements -Clarification of requirements -Methods for various tools and forms for controlling processes Areas Covered in the Webinar: -The Goal of Variation Management -Understanding the Mandates -Understanding the Conventions -Familiarity with the Terminology and Tools -Understanding the General Requirements and Differences that Customers may invoke -Examples of Various Approaches -Developing a Process Model -The 7 stages of Control -OEM Requirements Learning objective: The objective for this module is to give participants a solid understanding of what the core requirements are to controlling variation in processes as required in AS9103 Variation Management of Key Characteristics. Who Will Benefit: This webinar will provide valuable assistance to -Aviation/Aerospace Parts Manufacturers and Component Producers -Aviation Repair Stations/Maintenance Facilities -Parts/Stockist Distributors It will benefit personnel in job functions such as manufacturing and operations, quality, project management and planning, engineering, analyst, purchasing and marketing. Instructor Profile: Ted Herrmann, has been involved with the Aerospace/Aviation industry for over 30 years. Ted’s experience includes basic parts inspection to Class –A- Layout Inspection, Manufacturing Process Planning, Quality Process Planning and developing a combined Manufacturing/Quality Process Planning process. Ted has been involved in Quality Architecture developing Quality Management System processes, procedures and work instructions. Address: 2600 E. Bayshore Road , Palo Alto, California |
| 29 |
All about NAFTA and its Impact if You Have to Abide by It
- The webinar will provide detailed information on how to comply with NAFTA basics such as Harmonized Tariff classification, valuation, Country of Origin determination and marking requirements. Attendees will also learn how to comply with NAFTA’s often complex rules for eligibility thus mitigating the risk of violations that are subject to stiff fines and penalties from US, Canadian and Mexican Customs authorities. Why Should You Attend: While the purpose of the North American Free Trade Agreement (NAFTA) is to allow duty free or reduced duty status by moving goods originating in the NAFTA territory, it is wrought with complex regulations, especially in the area of Country of Origin determination. Many companies have unknowingly violated NAFTA by shipping merchandise that is not of NAFTA origin. Much of the confusion lies in that even though the product ships from one NAFTA country to another, it may have been purchased from a non-NAFTA originating country. Similarly, manufacturers often use a combination of NAFTA and non-NAFTA originating components that in many cases will not qualify the finished article for NAFTA origin. This webinar will address these complex regulations in detail with examples of how to correctly determine Country of Origin along with compliance in HTS classification and valuation. It will illustrate the complexities where incorrect application of the law may result in violations, thus leading to fines and penalties. The attendee will take away detailed knowledge of these regulations so that they may apply them to their current NAFTA sales programs to insure compliance with the NAFTA. This webinar will also contain a detailed discussion of how to use Annex 401 to determine the Regional Value Content (RVC) for Country of Origin determination of the finished article. It will dispel common myths and misunderstandings of shipping products under the NAFTA Rules of Origin. Areas Covered in the Webinar: -Overview of the NAFTA -General Rules of Origin A - F -Completion of the NAFTA Certificate of Origin -Recordkeeping Requirements -Questionnaires, Verifications and Audits -Penalties -Resources -NAFTA Risk Assessment Who Will Benefit: -Sales/Marketing -Exporters -Importers -Purchasing -Accounting -Shipping/Receiving -Engineering/Manufacturing -Customhouse Brokers -Compliance personnel completing the NAFTA Certificate of Origin -Customer Service -Logistics -Transportation -Legal Instructor Profile: David G. Ross, has specialized in Global Trade Compliance and Logistics Management from small business to Fortune 500 Companies for over 25 years. Mr. Ross has held mid to upper management positions in the industrial, consumer products, high technology freight forwarding/logistics and aerospace/defense industries. He has performed over 100 focused trade compliance assessments/audits for our clients. He has extensive experience as a duly empowered official (Atty in Fact as approved by the B.o.D) for Trade Compliance and Global Logistics in his corporate functions. He has established and chaired corporate compliance and logistics councils at the executive management level whose focus was both US export/re-export regulations and Supply Chain/Logistics optimization. He has also overseen responsibilities for direct shipments from overseas affiliates subject to US export controls on both product and technology transfer. He has developed Technology Control Programs (TCP) as well as implementing strategic security initiatives such as the Customs and Trade Partnership Against Terrorism (C-TPAT) and ITAR security controls with our clients. He possesses extensive experience in product classification and licensing for the Export Administration Regulations (EAR) International Traffic in Arms Regulations (ITAR), Bureau of Alcohol, Tobacco, Firearms and Explosives Regulations (BTAFE) and US Customs and Border Protection Regulations. For ITAR controlled articles, David has managed export licensing applications and authored Technical Assistances agreements for various defense contractors. Address: 2600 E. Bayshore Road , Palo Alto, California |
| 29 |
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan
- This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations. Why Should You Attend: Is your site carrying out clinical research in accordance with regulatory expectations? You have training requirements for investigators and coordinators, is that enough? Is it worthwhile training that covers necessary topics? A Quality Assurance (QA) Program is the vehicle to help you answer these questions and more. Quality assurance is often confused with monitoring or auditing. Understanding the principles of quality assurance and how QA differs from monitoring and auditing is critical to establishing a program that enhances compliance without creating unnecessary redundancy. This webinar will show how one can develop a mechanism for providing feedback from QA to enhance education and training of their investigators and coordinators. If you belong to a site, or work with a site, that relies on external sources - monitoring visits, IRB review, FDA audit, etc. - for evaluation and feedback, then your site will benefit from this training. In this 90-minute session, attendees will learn fundamental concepts and strategies to get their site started with a QA program that verifies clinical research practices as they are operationalized at the local site. Learning Objectives: At the end of this program attendees will be able to: -Describe the purpose of a Site Quality Assurance Program. -Differentiate a QA program, monitoring and auditing. -Utilize resources to evaluate a clinical research program. Areas Covered in the Webinar: -Elements of Quality Assurance Program. -Elements of Monitoring. -Elements of Auditing. -Roles and responsibilities of study team members. -Training and Education requirements. -Implementing change. Who will Benefit: This webinar will provide valuable assistance to following personnel: -Experienced Clinical Research Coordinators -Experienced Principal Investigators -Experienced Clinical Research Associates (Monitors) -Site Based Clinical Research Managers and Administrators -Regulatory Compliance Associates and Managers Instructor Profile: Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Currently employed by UCHealth Systems, (jennifer.holcomb@uchealth.org), she provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Jennifer has extensive experience in training and education and complete a 4 year term as Vice Chair of the ACRP Professional Development Committee. Address: 2600 E. Bayshore Road , Palo Alto, California |
| 29 |
This webinar will focus on the regulatory and design requirements for an effective change control system. Attendees will learn role and importance of
- This webinar will focus on the regulatory and design requirements for an effective change control system. Attendees will learn role and importance of change control system in implementing an effective quality system. Why Should You Attend: An effective change control system is one of the cornerstones of a productive organizational quality system. Change control can be instrumental in ensuring continuous control over changes to facilities, equipment, processes, specifications, and laboratory operations, etc. The importance of change control is emphasized by how it is stressed in regulatory inspections (FDA, EU, TGA, etc.) and in regulatory requirements. There are specific change control elements in cGMPs, ICH, and ISO requirements. All these are critical components of the latest regulatory guidelines on the implementation of quality systems. This webinar will help attendees understand the critical role that change control has in the successful implementation of a quality system and how it can be a vital element in achieving quality and ensuring regulatory compliance. Areas Covered in the Webinar: -Change control’s role in an effective quality system -Specific regulatory requirement for change control -ICH guidelines and Good Manufacturing Practices -Guidelines on change control’s role in regulatory inspections -Specific design requirements for a change control system -Key aspects of the role and key players involved in a change control system -Common problems encountered in change control -Recent regulatory trends and observations. Who will benefit: -Pharmaceutical Professional involved in the manufacture of products -API and Excipients Providers -Service Providers -All Levels of Management -Change Control Professionals -Quality Professionals Instructor Profile: Mr. Michael Ferrante, possesses a unique background in the field of pharmaceutical and biotechnology quality and compliance. Mr. Ferrante has held middle and senior management positions with companies such as Mayne Pharma, Schering-Plough, Glaxo Wellcome, Burroughs Wellcome, and Organon, Currently, he is President of Quality and Compliance Associates LLC, which provides consulting expertise to the pharmaceutical and healthcare industries regarding quality systems, regulatory compliance, FDA Interactions, and organizational evaluations and improvements. Address: 2600 E. Bayshore Road , Palo Alto, California |
| 2 |
Anti-Corruption Program including the Foreign Corrupt Practices Act (FCPA)
- This webinar will explain the anti-bribery and accounting provisions of the Foreign Corrupt Practices Act (FCPA) and will also discuss the UK Bribery Act. Learn the best practices for avoiding penalties for FCPA, UK Bribery Act, or local law violations. Why Should You Attend: The U.S. Government has significantly increased the enforcement of Foreign Corrupt Practices Act (FCPA), and a record number of companies have been fined and penalized for violations. This is a challenging area for multinational companies in which to enforce compliance in each country they operate regardless of the size of the operation. In addition to the U.S. corruption law, many other countries have similar laws such as the United Kingdom, China, Columbia, India, and Canada. The FCPA has two key parts which are the Anti-Bribery provisions and the Accounting provisions. This webinar will explore each of the key provisions of the FCPA, and how one can implement a practical program to mitigate risk in this area. Areas Covered in the Webinar: -Elements of the FCPA -United Kingdom Bribery Act -Key anti-corruption and bribery laws that regulate business conduct -Recognize and avoid potential FCPA, UK Bribery Act, or local law violations -Identify when and where to seek assistance -Establishing a proactive program to mitigate risk in this area Who Will Benefit: -Finance professionals -Internal audit -Business operations management -Compliance officers -Executive management -General/corporate counsel -Regulatory/legislative affairs professionals -Risk management specialists -Sales/marketing personnel -Training personnel -Consultants -International business operations Instructor Profile: Robert Brewer, is currently associated with JPA International. Mr. Brewer served as Senior Vice President and Chief Compliance Officer for Office Depot from 2005 until the end of 2013. In this role, he had overall responsibility for compliance activities on a global basis for a retailer who provided supplies and services to its customers through 2,200 worldwide retail stores, have annual sales reaching $17 billion, employing 66,000 associates around the world. Office Depot provides more office supplies and services to more customers in more countries than any other company, and currently sells to customers directly or through affiliates in 59 countries. Among other functions, global internal audit, loss prevention, risk management functions and social compliance reported to him. He had direct reporting relationship with the Audit Committee of the Board with respect to audit and risk assessment matters. He also served as the Chair of the Board of Directors for the Office Depot Foundation providing resources and product valued at over $12 million annually. He previously served as Vice President of Global Corporate Audit Services for six years. Address: 2600 E. Bayshore Road , Palo Alto, California |
| 2 |
Risk based Computer System Validation for SaaS/Cloud/Local Hosting
- Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable. Why Should You Attend: This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement. Areas Covered in the Webinar: -Learn which documents the FDA expects to audit. -Proven techniques that reduce software costs and implementation times. -Increase corporate productivity and individual workforce member productivity. -Efficiently create validation documentation. -Requirements for SaaS and cloud hosting. -Decrease resource requirements. -Make documentation more manageable and understandable. -Avoid 483s and Warning Letters. -How to implement a computer system to gain maximum productivity. -Use resources effectively to perform effective validation while avoiding doing too much. -How to link requirements, specifications, risk management, and testing. -Document a computer system validation project using easy to understand fill-in-the-blank templates. -Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006). Who Will Benefit: -Computer System users -IT -QA -Managers -Executives Instructor Profile: Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. Address: 2600 E. Bayshore Road , Palo Alto, California |