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 Lim
President& Principal
RegulatoryDoctor
Date and Time : Thursday, August 7, 2014
10:00 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-Columbiaand 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-makingprocesses. 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 California94536 USA | susanpartov@onlinecompliancepanel.com
Copyright © 2014 OnlineCompliancePanel.com
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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
Introductionto 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 Korea
This 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
Preparingfor FDA BIMO Inspection and Management
This 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 Control
According to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters.
RecordedSession Access recorded sessions for multiple participants unlimited viewing for 6 months.
Putting together a Q-Submission and 510(k): Best Practices
This 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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Establishinga Medical Device Reporting System Integrated with a UDI System
This 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).

Implementingan Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820
This 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.
FDA 510(k): Trends, Hurdles, Submissionand Clearance
This webinar is intended to help you get familiar with the recent FDA 510(k) trends, hurdles, and submission and clearance.
FDA BIMO Inspection: Preparationand Management:Dos and Don'ts
This 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 LaboratoryPractice (GLP) Inspection Preparationand Management: Dos and Don’ts
This 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 SubmissionCompliant with eCopy and RTA Policy
This 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.

Implementinga Unique Device Identification (UDI) system
This 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 IVDs
Have 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 Preparationand Readiness: Dos and Don'ts
This 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 policy
This 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 Regulationsin China, Hong Kong, Japan and Korea
This 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 RequirementsCompliant with eCopy and RTA Policy
This webinar is intended to discuss the premarket notification [510(k)] requirements compliant with eCopy and Refuse to Accept Policy (RTA) requirements.
RecordedSession Access recorded sessions for multiple participants unlimited viewing for 6 months

Quality ManagementSystems for Medical Devices and IVDs
FDA 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 Devices
This 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.
ImplementingMedical Device Reporting
This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.
Requirementsfor 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 Management
This 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 Devices
FDA 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 Studies
This 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 Removals
In 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.
Improving510(k) Submission Quality
This 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 Complaints
Medical 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 Cleared
This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
510(k): Submissionand Clearance
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).

Best Practices and FDA-CompliantMedical Device Reports (MDRs), Recall, Corrections and Removals
In 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 System
All 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).
ImplementingDesign control for Medical Devices and IVDs
Device 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.
For more details on our upcoming webinars , please visit:
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Best practices : Preparing for FDA inspection and management including GLP inspection

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Best practices : Preparing for FDA inspection and management including GLP inspection