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CMC regulatory compliance deficiencies have resulted in clinical holds and delays in market approval. Additionally, CMC regulatory shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are presented in this class. This three-day course will also present a strategy to obtain a cost-effective, risk-managed CMC compliance strategy partic...

This two-day course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues, but is valuable to anyone looking for a refresher or a means to stay current with regulatory agency thinking. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; ho...

This educational activity will outline the basic regulatory requirements regarding the proper handling and disposal of pharmaceutical hazardous waste and the background needed to understand the regulatory scheme and regulatory “triggers” so you can determine which regulations apply to these compounds. We will outline potential penalties for non-compliance regarding the proper handling and disposal of pharmaceutical hazardous waste. We will also discuss NIOSH listed hazardous drugs (chemo...

mployers continue to push through the toughest economy in decades, awash with a tsunami of EEO charges and employment lawsuits, fighting the tidal wave of wage and hour claims, and adjusting to a regulatory-focused administration in Washington. Staying ahead of the trends is the best means of protecting your organization in a time of unprecedented employment law risk, legislative and regulatory activity. This seminar guides you through a multitude of employment issues, to better focus your com...

This course is designed for personnel who are responsible for understanding Japan’s regulatory environment and business practices within the Pharmaceutical and Biotechnology industries. Individuals with responsibility for ensuring compliance with regulatory filings and adhering to overall regulatory requirements will also find this training highly relevant . Additionally, this training program will provide detailed knowledge to business development professionals seeking to either licen...

This two-day course is designed to give participants of all levels a strong foundation in the fundamentals of FDA regulatory compliance for drugs and biotech products. Additionally, this course will detail how to meet compliance objectives in a cost-contained manner. Upon completion of the course attendees will understand the guidelines, philosophy and practical approach to FDA compliance. Participants will have a firm grasp of the seven key strategies to cost-effective compliance, includ...

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of regulatory agencies in Latin America. Content will...

This course will review a process for closing the gap between regulatory requirements and study execution. Participants will acquire strategies for risk management in the areas of regulatory compliance, protocol execution and participant safety. Guidance documents important to pediatric research will be reviewed within the context of case studies from completed programs. Participants will be given an opportunity to share their experience during working sessions on protocol design and ethical i...

This two-day course is designed for all scientists (managerial and laboratory), regulatory affairs and compliance personnel who are active in pre-clinical studies and in other laboratory settings. The course will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of data from pre-clinical studies. By the end of the course, attendees will have a strong understanding of the fundamental compliance requirements for current Good...

This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to Validation & Verification (V&V), risk analysis and the FDA’s supplemental guidelines. An ISO perspective is offered to compliment the FDA view. Among the topics to be discussed are: Context of V&V and risk analysis within the overall quality system and regulation; V&V and Risk analysis procedures; V&V methodologies; V&V strategies; ty...

This two-day course is designed for all persons who are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control Analytical Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laborator...

This two-day course is designed for those who manage, audit, or oversee manufacturing of OTC drug products, and for cosmetic manufacturers with OTC drug products (no dosage) performing their operation under a drug cGMP environment. The course will cover regulatory expectations as contained in U.S. and International guidelines. It will prepare attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps, and execute a plan to achieve comp...

October 24, 2011, The Centers for Medicare and Medicaid Services (CMS) published proposed changes for hospitals. These would affect any hospital that accepts Medicare or Medicaid which are most hospitals in America. This is one of the major revisions in more than two decades. These were written to comply with the President’s mandate to reduce the regulatory burden placed on hospitals. Interesting to note a consideration in reduction of the hospital conditions of participation in the past yea...

This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus is placed on basic regulation and the FDA’s supplemental guidelines. Among the topics to be discussed are: the context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general qualit...

Flexible dates and times available EVERY WEEK from: October 3, 2011 - September 28, 2012 Monday - Friday 8:00 - 12:00 p.m. Begin any weekday. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE cred...

Every Week, October 3, 2011 - September 28, 2012 Monday - Friday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and ...

Every Week, October 3, 2011 - September 28, 2012 Monday - Friday 8:00 - 12:00 p.m The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and ...

Every Week, October 3, 2011 - July 27, 2012 Monday - Friday 8:00 - 12:00 p.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and even...

Every Week, October 6, 2011 - October 1, 2012 Thursday - Monday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and...

Summer Every Week, June 18, 2012 - August 17, 2012 Monday - Friday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk an...

Every Week June 25, 2012 - August 17, 2012 Monday - Friday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and even vi...

Every Week, October 3, 2011 - September 28, 2012 Monday - Friday 8:00 - 12:00 p.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and...

Every Week, February 27, 2012 - September 28, 2012 Monday - Friday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk a...

Every Week, March 5, 2012- September 28, 2012 Monday - Friday 7:30 - 11:30 a.m. The course is a unique, 20 hour survey of the intersection of medicine and law as well as selected clinical topics. The 2011-12 Medical-Dental-Legal Update is produced in state-of-the-art production studios using broadcast-grade digital technology and is approved for up to 20 AMA PRA Category 1 CME Credits™ as well as extensive CLE and CE credit. Learn to reduce your malpractice and regulatory risk and e...

Intermediate Level: Compliance plays a very important role in helping to preserve and protect Medicare dollars. This course will provide the key elements a compliance program needs in order to help monitor documentation and coding. In addition, information will be presented on how to implement a good quality assurance program for documentation, including the basics of the audit and medical review programs utilized by Medicare.

Upon completion of this activity, you will be able to: * list the communicable diseases and define the regulatory authority under which allogeneic blood donations must be tested. * list the communicable diseases and define the regulatory authority under which autologous blood donations must be tested. * define the risk versus benefit of storing and transfusing autologous blood that is known to be reactive/confirmed positive for a communicable disease test. * define the risk versus...