Description: Biotech consultant Chitra Edwin presents the 10 key elements FDA inspectors look for in GLP audits and explains what to do to pass inspection on all counts. Areas covered include:

• Facilities and equipment;
• Organizational structure;
• Protocols and procedures; and
• Data and document management.

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Speaker: Chitra Edwin Ph.D RAC, Principal, Biotechnology Consulting Solutions

Description: Quality and organization expert Dan O’Leary provides advice on how to craft supplier quality agreements that meet regulators’ requirements. O’Leary discusses:

• Quality System Regulation requirements for purchasing;
• Supplier qualification;
• Scope and primary elements of a supplier agreement; and
• Working with third-party suppliers.

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Speaker: Dan O’Leary, President, Ombu Enterprises LLC

Description: Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud. The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.” The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury? Learn more about this controversial proposal in this presentation.

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Speakers: David Clissold, Director, Hyman, Phelps & McNamara and Nisha Shah, Associate, Hyman, Phelps & McNamara

Description: Regulatory specialist Gina Ross shows how to create a content development and organization strategy for developing electronic Common Technical Documents and how to develop authoring SOPs that ensure global compliance. Ross discusses:

• How to train staff to write eCTDs;
• Managing the document throughout its lifecycle; and
• The decision-making process for most effective integration of regulatory strategies and eCTD lifecycle management

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Speaker: Gina Ross, Manager of the Regulatory Publishing Department, Beckloff Associates Inc.

Description: Certified quality auditor Robert Schiff describes his experiences as a veteran of numerous GMP inspections and points out the 10 most commonly noted violations. Schiff discusses:

• CAPA failures;
• Lack of out-of-specification, nonconformance and deviation investigations;
• Inadequate complaint handling; and
• Failure to follow established SOPs.

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Speaker: Robert Schiff Ph.D., CEO, Schiff & Company

Description: Validation expert Rich Yeaton reveals the front-line cleaning validation techniques needed to stay FDA compliant. Yeaton discusses:

• Developing and implementing a Cleaning Validation Master Plan;
• The three key parts of a cleaning validation program;
• Cleaning acceptance criteria; and
• Appropriate analytical methods.

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Speaker: Rich Yeaton, President, East Coast Validation Services LLC

Description: Dietary supplements expert Ivan Wasserman discusses how FDA adverse event reporting rules apply to OTCs and supplements just as they do to prescription drugs and explains all facets of the reporting process, including:

• How to identify adverse events;
• Collecting data on the event;
• Documenting the event; and
• Reporting procedures.

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Speaker: Ivan Wasserman, Partner, Manatt Phelps & Phillips LLP
 

Description: Clinical trial specialist Charles Pierce educates research facilities and investigators on how to identify and report on adverse events that occur in their trials and make sure they comply with FDA’s and other authorities’ requirements. Pierce covers:

• Definitions and types of adverse events;
• Investigators’ responsibilities;
• Monitoring and reporting adverse events and managing risk; and
• Common mistakes in reporting.

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Handout – Adverse Event Study Medication Relationship

Speaker: Charles H. Pierce MD, PhD, FCP, CPI, Pierce One Consulting