What to do and what not to do when it comes to testing and retesting FDA regulated products in the medical device, pharmaceutical and food industries is what this webinar is about. When an out of specification (OOS) test result is obtained during product release or during product validation testing, the scientists dealing with retesting need to understand the FDA rules and expectations about repeating their testing. This is prescribed in the FDA guidance document, which will be clearly explained in this webinar. Auditors and Auditees in regulated industries will walk out of this webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation of all sorts of OOS test results in today’s highly regulated industries.
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
Why Should You Attend
Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Additional copies are available from: Office of Training and Communication Division of Drug Information HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2006 Pharmaceutical CGMPs
- Will review FDA expectations based on their Guidance document for OOS
- Will incorporate several OOS examples based on the FDA Guidance Document for dealing with OOS Test results so you can integrate them into your company SOPs
- Will discuss pathways for successfully interpreting regulatory expectations for retesting
- Will educate you on practically dealing with OOS results for medical devices, pharmaceutical and food industries for USP testing, non USP chemical, microbiological and physical testing will be described in this presentation.
- Help you to successfully address testing related questions raised on OOS in several FDA and regulatory audits.
- Will share many practical examples from which you can lay a strong foundation for successfully dealing with Out of Specification (OOS) Test results in your FDA Regulated Industry
- You will learn to do the right testing, prevent mistakes and avoid FDA 483s for testing discrepancies.
Who Will Benefit
- Quality Control lab personnel involved in testing and releasing FDA regulated products
- Product development and QA scientists who review test results
- Medical device, pharmaceutical and food manufacturing facilities who encounter failing test results and need to know a path forward
Faculty Meena Chettiar
Director, Quality and Regulatory Affairs at Welly Health PBC
Greater Minneapolis-St. Paul Area
Meena Chettiar, has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical and medical device industries for over 25 Years in Canada and the United States. During this time Meena has had the opportunity to be audited by the US FDA several times answering questions on OOS. Meena has also performed several ISO audits in the United States and overseas. She is therefore, very proficient in FDA OOS expectations in the FDA regulated industry. Meena holds several certifications in Quality from the American Society for Quality(ASQ).
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.