ComplianceOnline

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Instructor: Kim Huynh-Ba
Product ID: 703278
  • 23
  • January 2018
    Tuesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min

Live Online Training
January 23, Tuesday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$229.00
One Dial-in One Attendee
$499.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

Why Should You Attend:

Most of the activities during an inspection traditionally may be handled by the quality assurance group; however, more and more often, technical personnel are needed to address questions from regulatory agencies. Therefore, handling an inspection is a very critical activity. Clear and concise presentation of information will aid the regulatory agency in their review.

This webinar will discuss the important structure of a regulatory agency’s inspection and the key behaviors needed to ensure that appropriate information is presented. Proper recordkeeping and documentation will be discussed as will how best to cite and prepare summaries of the observations.

Areas Covered in the Webinar:

  • Determine the sequences of an inspection
  • Good recordkeeping for GMP and non-GMP studies
  • Establish a process of handling an inspection
  • Presenting clear and concise information
  • Train your personnel to handle an inspection
  • Keep clear and concise records of observations

Who Will Benefit:

  • Regulatory Affairs
  • Quality Assurance/Control
  • Analytical Chemists
  • Auditing
  • Scientists
  • Research & Development
  • Quality Systems Management
  • Documentation Management
  • VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
Instructor Profile:
Kim Huynh-Ba

Kim Huynh-Ba
Founder and Technical Director, Pharmalytik

Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

Kim is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. Kim currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. Kim is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.

Kim has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices" (2008) and "Pharmaceutical Stability Testing to Support Global Markets" (2010).

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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