best practices : preparing for fda inspection and management including glp inspection

Preparing for FDA Inspection and Management including GLP Inspection: Best Practices

A Live Webinar by David Lim

David LimPresident & PrincipalRegulatory Doctor

Date and Time : Thursday, August 7, 201410:00 AM PDT | 01:00 PM EDT

About Heath Rushing :

Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.

Phone Number: 510-857-5896 | Fax Number : 510-509-9659 | Address : 38868 Salmon Ter, Fremont California 94536 USA | [email protected]

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Program Objectives:

•Applicable Laws and Regulations •Definitions •FDA Manuals •FDA GLP Inspection Scope •Inspection Classification, Types and Categories •FDA Inspection Process and Assessment of Compliance •Dos and Don'ts Before, During and After an FDA GLP Inspection •Close Out Meeting •Responding to 483s, If Issued •Common Deficiencies •How to Answer Questions •Employee Training •Actual Case Studies •Best Practices •Speaker's PASS-IT Recommendations/Suggestions

Introduction to Preparing for FDA Inspection and Management including GLP Inspection: Best Practices

This webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don'ts. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the FDA GLP inspection will be discussed.

This webinar will provide practical, actionable and sustainable guidance for you to dramatically improve your current practices with awareness and beyond, significantly contributing to hosting successful FDA inspections.

This 60-min webinar will offer great opportunities for you to apply and execute your FDA GLP inspection preparation and readiness in a way to significantly improve your current processes while preparing for a successful FDA GLP inspection in an efficient and effective way.

Why Should you Attend:

Attend this webinar and you would learn the best practices in GLP such as labeling all reagents and solutions in the lab to indicate identity, concentration, storage requirements and expiration date; making sure each individual engaged in or responsible for the supervision of a study or analysis should have education, training, and experience or a combination of everything to enable that individual to perform the assigned function and setting up a protocol in place for each study.

Preparing for FDA Inspection and Management including GLP Inspection: Best Practices






Other Upcoming Live Webinar by David Lim

Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and KoreaThis webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.

Live Session Thursday, June 26, 2014 10:00 AM PDT | 01:00 PM EDT, Duration:60 minutes


Archived Webinar by David Lim

Preparing for FDA BIMO Inspection and ManagementThis webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm's preparation and readiness for an FDA BIMO inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization.

Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.

FDA Inspection and Medical Device Design ControlAccording to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters.


Putting together a Q-Submission and 510(k): Best PracticesThis webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.


Establishing a Medical Device Reporting System Integrated with a UDI SystemThis webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).



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Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820This webinar is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection or for those who are subject to ISO 13485 and/or 21 CFR Part 820.

Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months .

FDA 510(k): Trends, Hurdles, Submission and ClearanceThis webinar is intended to help you get familiar with the recent FDA 510(k) trends, hurdles, and submission and clearance.


FDA BIMO Inspection: Preparation and Management: Dos and Don'tsThis webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm’s preparation and management for an FDA BIMO inspection can be done in a more effective, meaningful and easily manageable manner at all levels of organizations.


FDA Good Laboratory Practice (GLP) Inspection Preparation and Management: Dos and Don’tsThis webinar is intended to help you get familiar with FDA Good Laboratory Practice (GLP) Inspection and Preparation – Dos and Don’ts. We discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don’ts before, during and after the FDA GLP inspection will be discussed.


FDA 510(k): Good Practices for 510(k) Preparation and Submission Compliant with eCopy and RTA PolicyThis webinar is intended to discuss good practices for premarket notification [510(k)] preparation and submission compliant with eCopy and Refuse to Accept (RTA) Policy requirements.


















Implementing a Unique Device Identification (UDI) systemThis webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules and adequately implement a UDI system in accordance with the final rules, issued on September 24, 2013.


Overview of FDA Regulations for Drugs, Biologics and Medical Devices including IVDsHave you ever wondered what regulations are applicable for drugs, biologics and medical devices during preclinical, clinical and postmarket phases? This webinar is intended to help you get familiar with the US regulations governing drugs, biologics, and medical devices including in vitro diagnostic medical devices (IVDs).


Good Practices for an FDA Inspection Preparation and Readiness: Dos and Don'tsThis webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection. This webinar discusses emotional intelligence (EQ)-based practical and actionable guidance on how to proactively prepare for and get ready for a successful FDA inspection: in particular, a list of Dos and Don'ts before, during and after the inspection will be discussed.


FDA 510(k) Update: Recent Trends and Good Practices Compliant with eCopy and RTA policyThis webinar is intended to get familiar with the recent 510(k) trends and to help you implement good practices for your successful 510(k) preparation, submission and clearance.


Medical Device Laws and Regulations in China, Hong Kong, Japan and KoreaThis webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.


510(k): Regulatory and Technical Requirements Compliant with eCopy and RTA PolicyThis webinar is intended to discuss the premarket notification [510(k)] requirements compliant with eCopy and Refuse to Accept Policy (RTA) requirements.

Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months























Quality Management Systems for Medical Devices and IVDsFDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"


EU Medical Device Directive: Preparing for Conformity Assessment Application for CE Marking of Medical DevicesThis webinar is intended to help you get familiar with the European Union (EU) Medical Device Directive (MDD) governing medical devices for CE marking. This webinar is further intended to provide guidance on the regulatory requirements set out in the MDD, which helps ensure that medical devices are safe and effective for their intended use.


Implementing Medical Device ReportingThis webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.


Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)This webinar is intended to discuss the requirements for medical device developers to meet the U.S. FDA's requirements on the 510(k).


FDA Inspection: Preparation and ManagementThis webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection.


cGMP for Medical Devices Including In Vitro Diagnostic Medical DevicesFDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.


















510(k): Format, Contents and Case StudiesThis webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance.


Best Practices for MDRs, Recalls, Corrections, and RemovalsIn the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.


Improving 510(k) Submission QualityThis webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.


Best Practices Compliant with the FDA Regulations for Handling Medical Device ComplaintsMedical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.


510(k): How To Navigate Through Hurdles And Get It ClearedThis webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.


510(k): Submission and ClearanceA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).


















Best Practices and FDA-Compliant Medical Device Reports (MDRs), Recall, Corrections and RemovalsIn the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.


Best Practices for Establishing a Compliant Medical Device and Complaint Handling SystemAll medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.


510(k) Submission: Contents and Format for Medical Devices A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).


Implementing Design control for Medical Devices and IVDsDevice manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements.





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