Law Events in California

The Sunshine Act Reporting for Clinical Trials

san Francisco, California, USA

Description: Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare. Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicai...

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Advancing GRC Efforts through the Evolution of ERM

Palo Alto, California, USA

This webinar on advancing GRC efforts through the evolution of ERM will cover how to effectively converge ERM and GRC program and evaluate actions required to ensure your company’s strategic efforts to achieve the ultimate goal of strategic corporate value. Why Should You Attend: For almost two decades, there has been considerable discussion and frustration about the pace of change in embracing ...

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Changing Supplier Controls Requirements

Palo Alto, California, USA

This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. Why Should You Attend: Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing wi...

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Study to Support Shipping and Distributing Pharmaceutical Products

Palo Alto, California, USA

This training on pharmaceutical stability studies will highlight the key factors that would affect the shipping and distribution of drug products. It will explain the stability studies that need to be done to support shipping and distribution of drugs. Why Should You Attend: Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and bi...

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Validation of Cleaning: An Essential Tool to Remove Food Allergens

Palo Alto, California, USA

This webinar on cleaning validation for food allergens will provide guidance on how to develop and implement an effective cleaning validation plan, customized for specific scenarios, to ensure that the allergen is removed from the food processing line or equipment. Why Should You Attend: The session will provide useful example scenarios to demonstrate effective cleaning regime and non-effective...

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Preparing Your Bank for BSA Audit

Palo Alto, California, USA

This BSA (Bank Secrecy Act) compliance training will highlight how a bank can best prepare for a successful BSA audit as acknowledged and recognized by regulators and examiners. Why Should You Attend: The areas of focus outlined in this webinar are based on best industry practice, supervisory experience and cover the major components of an effective BSA program that audits focus on. Attendees wi...

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Effective Anti-money Laundering Program - Financial Fraud Detection, Prevention

Palo Alto, California, USA

Anti-Money Laundering (AML) activities will help to prevent the use of financial institution or its infrastructure for money laundering purpose by criminal elements. This 90 minute webinar will discuss in detail the importance of appropriate internal controls implementation that is specific to money laundering in order to detect activities defined as suspicious under the laws of a given jurisdicti...

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Meeting the FDA for Orphan Products: Practical Strategies to Maximize Benefit

Palo Alto, California, USA

This training on orphan products will discuss FDA's guidance documents and the do’s and don’ts at FDA meetings for orphan products. It will explain proven techniques in preparing for FDA meetings using case-studies to highlight common mistakes and potential solutions. Why Should You Attend: Orphan products require special interactions with the FDA reviewers. Formal meetings with the reviewers no...

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Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

Palo Alto, California, USA

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries. Why Should Attend: The medical devices are currently one of the fastest growing industries. The knowledge an...

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How to Write a Safety Plan that Complies with OSHA Requirements

Palo Alto, California, USA

This webinar will be a basic, nuts and bolts program leading participants through the process of creating a written safety plan for evacuation, fire, hazard communication and Others, that complies with OSHA requirements. Why Should You Attend: The current Federal OSHA administration is taking steps to require employers to create and enforce Injury and Illness Prevention Programs, what they refer...

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What Accounts Payable and Purchasing Don't Know About Regulatory Compliance and How It Can HURT

Palo Alto, California, USA

This purchasing and accounts payable (AP)regulations training will focus on the necessary steps to be taken to avoid compliance issues, penalties and lawsuits. It will also explain how to identify an organization’s weaknesses and how to address the challenges related to AP and purchasing compliance. Why Should You Attend: Revenue shortfalls at all levels of government have greatly increased scr...

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The Infamous Form FDA 483: How you respond can make or break you

san Francisco, California, USA

Description: The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations. The issuance of a 483 by the CSO at the ...

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Moving your Vaccine Product from the Lab to Humans

Palo Alto, California, USA

This training on vaccine development and approval will outline step-by-step procedures that need to be followed inorder to bring your vaccine candidate from the laboratory to human testing and consumption. Why Should You Attend: Most of the scientists working on the pre-clinical stages of vaccine development do not fully understand what is the process that the vaccine candidate must follow in or...

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Disinfectant Validation And Cleanroom Cleaning For All FDA And EMEA Regulated Companies

Palo Alto, California, USA

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues. Why Should You Attend: Designing an effective cleaning and disinfection program is a critical part of your facility operations and contamination control program to meet FDA, EMA, a...

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When FMLA ends and ADA begins. The FMLA/ADA Crossover

Palo Alto, California, USA

This 90-minute training will assist you in understanding the complex interaction between FMLA and ADA (AA) as it relates to intermittent leave requests with an underlying accommodation. In addition, we will clarify and discuss strategies for managing the transition from FMLA to ADA, concurrent ADA compliance requirements when designating FMLA, and the significant differences between the compliance...

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Working with Immigrants: The Intersection of Basic Immigration, Housing, and Domestic Violence Issues in California (Free)

San Francisco, California, USA

You should attend this training if you would like to provide pro bono services to immigrant clients in the areas of housing, immigration, or domestic violence or you would like to improve your representation of immigrant clients generally.  Many immigrant clients require assistance with a constellation of related yet distinct issues.  This day-long program attempts to address these parti...

Practising Law Institute

Medical Device Complaints, MDR’s and Recalls

Palo Alto, California, USA

This webinar on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls. Why Should You Attend: All Medical Device firms need to be aware of the benefits of compliance, as well as the dangers of inadequate complaint handling. Many medical device firms face regulatory issues a...

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Communicating with Patients and Complying with HIPAA - How to Use E-mail and Texting

Palo Alto, California, USA

This HIPAA compliance training will explain how HIPAA requirements for privacy and security can be reconciled with patient requests for information to be provided by e-mail and text messages. Why Should You Attend: E-mail and texting present new challenges to health care providers, as there are simultaneously new requirements to share information with patients, and a new enforcement effort to en...

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MSRB Rule G-14: Reports of Sales or Purchases (RTTR) and FINRA Rule 6700:

Palo Alto, California, USA

The MSRB and FINRA compliance training will teach you all of the complicated aspects of RTTR (Reports of Sales or Purchases) and TRACE (Trade Reporting and Compliance Engine) in a way that is laid out for ease of understanding and learning. Why Should You Attend: This MSRB and FINRA regulations training draws on the expertise of veteran regulatory compliance officers with over 40 years’ combined...

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Global Trademark Search and Application Workshop 2013

San Francisco, California, USA

Join a faculty of domestic and international legal experts as they provide practical guidance for the trademark search and application process in the U.S. and abroad.  Using real-world examples, this practice-based, hands-on workshop will get attendees involved and provide takeaway tips that can be put into use in daily practice immediately.  Learn about the differences and similarities ...

Practising Law Institute

Information Technology Law Institute 2013: Privacy and Cybersecurity, Mobile Advertising, Digital Distribution, Social Media and the Third Industrial Revolution

San Francisco, California, USA

Virtually every American business has turned to technology to improve efficiency and deliver new, Internet-based services or information.  The fastest growing companies in our troubled economy are the technology innovators.  Every lawyer in this rapidly changing economy must understand the legal issues raised by technology.  However, when technological changes outpace the law, lawye...

Practising Law Institute

Privacy and Data Security Law Institute (Fourteenth Annual)

San Francisco, California, USA

This program focuses on critical issues of information privacy, security and data protection faced by all companies. The Internet and other evolving information technologies, wired and wireless, have prompted the development of powerful tools for the collection, processing, storage and use of personal information. These trends create numerous issues regarding limitations on corporate rights to use...

Practising Law Institute

Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

san Francisco, California, USA

Description: Medical foods play an important role in the management of patients with special dietary restrictions and needs. The designation of medical food by FDA implies special handling, labeling, distribution and manufacturing requirements. Manufacturers are usually worried about meeting all of FDA’s complex requirements for such products. This seminar will discuss the regulatory processes to ...

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Approaching Veterans Issues: A Legal Overview Including an Update of California Penal Code Section 1170.9

San Francisco, California, USA

Certain laws and courtroom practices have the potential to impact veterans differently than the rest of the population. This three hour overview will provide useful information to attorneys, judicial officers and others who interact with veterans about the implications of certain laws and practices with regards to veterans’ pasts and futures. The program will focus on Penal Code 1170.9, especially...

Practising Law Institute