Navigation Links
FDA 483s and Warning Letters list inadequate CAPA practices! What are Medical Device Manufacturers doing about it?
Date:10/22/2013

DURHAM, N.C., Oct. 22, 2013 /PRNewswire-iReach/ -- The main goal of Corrective Action and Preventive Action (CAPA) is continuous improvement. CAPA's aim is to collect and analyze information, investigate product, and check the overall quality before taking the necessary action be it corrective or preventive— to avoid non compliance. CAPA practices are one of the common non-compliance issues identified by the auditors. To prevent that, organization must understand the FDA's expectation instead of using the same process over and over again.

CAPA Practices for FDA Regulated Industry: Practical Tips to Meet FDA's Expectations

According to most FDA 483s and Warning Letters, insufficient CAPA practices are the most common findings. Misunderstanding related to FDA's expectations has led to non compliance and excessive cost and labor. Join Dr. Mukesh Kumar in this power packed session, where he will list step-by-step process to assure CAPA practices meet FDA's expectations. He will shed light on previous case studies to highlight common mistakes and ways of avoiding them. In addition, he will provide invaluable tips to create SOPs, management policies, and training methods to withstand an FDA audit. In this informative 60 minute, Dr.Kumar will discuss the regulations, FDA training processes specific to CAPA, and best practices for compliant facilities. Case studies from drugs, biologics and medical device facilities will be used to highlight common errors and acceptable solutions.

Areas covered in the session:

Know the requirements of the CAPA process and procedure

Elements of the CAPA file and their intended purpose

CAPA documentation processes including CAPA plan, SOPs, and written policies

Find out the best practices for CAPA process

Management oversight and monitoring CAPA activities

Case studies on site specific issues

Use AEOCT10 to get 10% discount, Applicable on all purchases.

Other Conferences Of The Week

Hospice Relationships With Nursing Homes: Government Scrutiny Is Increasing So You Need To Be More Vigilant

Due to potential for referrals, OIG has many concerns about the relation between hospices and nursing homes, as many hospices provide care to nursing home residents. OIGs concerns have been increasing over time, and have shifted from scrutinizing contractual relationships to scrutinizing the care provided to residents of facilities. Join expert speaker Robert Markette in this informative session, where he will provide an overview of number of OIG alerts, bulletins and guidance documents to identify red flags for these relationships.

Compliance Update- Key Physician Targets To Prepare For In 2014

In this information packed session, renowned expert Elin Baklid-Kunz, MBA, CHC, CPC, CCS, will provide you an overview of the OIG 2014 Work Plan for physician as well as a list of must-have physician resources for medical coding compliance. You will get the compliance update and key physician targets to prepare for in 2014 in this session. Plus, she will help you comprehend the increased OIG focus on high-level E/M services, and also highlight E/M risk areas, including EHRs and cloning.

AudioEducator brings you the most compelling audio conferences on a wide array of healthcare topics through revealing conferences. Get updated on topics like—medical coding, billing to CPT changes, E/M Modifiers to OIG work plan, Affordable Care Act to ERISA, RAC updates to fee schedule, Electronic Health Record system to ICD 10 transition, and more. Get trained from the comfort of your home or office without spending a penny on travel. Moreover, you can pick a medium of your choice for training, take your pick from live conference/On Demand/ CD/ PDF transcripts.

To learn more about other updates events for more than 20 specialties, please visit 2014 Medical CPT Coding Updates.

Media Contact: Adam K, Audio Educator, 1-866-458-2965, customerservice@audioeducator.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE Corrective Action and Preventive Action (CAPA)
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Warnings for Hepatitis B Reactivation in Cancer Patients Welcomed by the American Association for the Study of Liver Diseases
2. What Are the Warning Signs of a Failing Transvaginal Mesh Device?
3. The World Customs Organization (WCO) and the Institute of Research Against Counterfeit Medicines (IRACM) issue a new warning about the health and safety of African populations
4. CorePharma Addresses Violations in FDA Warning Letter
5. TorkLaw Responds to FDA Warning Letter to St. Jude Medical Regarding Defective Heart Device; Now Representing Patients in 15 States
6. Physician-Patient Alliance for Health & Safety: Addressing The Joint Commission Opioid Warnings Can Reduce Respiratory Depression and Improve Patient Safety in Hospitals
7. First Warning Systems Receives Investment by Members of the Reno Angels and Local Investors
8. National Sleep Expert Issues Warning about Popping Pills to Replace Sleep
9. Lifeline Biotechnologies First Warning Systems
10. Warning: Not All Cold Sore Medicines Are Created Equal
11. CVS Caremark Sponsored Research Finds FDA Drug Warnings Can Have Immediate Negative Impact on Medication Adherence, Even if Not Related to Safety
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... 20, 2017  RXi Pharmaceuticals Corporation (NASDAQ: RXII), ... address significant unmet medical needs, today announced that ... consumer product development program, based on its proprietary ... Investigative Dermatology (SID) 76 th Annual Meeting.  ... the sciences relevant to skin health and disease ...
(Date:4/20/2017)... --  ZappRx, Inc ., a digital health company focused on ... it closed $25 million in Series B funding led by ... Seattle that is part of a ... B round included participation from SR One , who ... (formerly Google Ventures). As part of the financing, ...
(Date:4/20/2017)... , April 20, 2017 Eyevensys, ... the first non-viral gene expression technology that enables the ... eye to address a wide range of ophthalmic diseases, ... and Healthcare products Regulatory Agency (MHRA) to advance its ... ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Somnoware, a leading ... Word(TM) Online(TM), which enables sleep physicians to create and edit their interpretation reports. ... and provides a familiar interface that does not require additional training to use. ...
(Date:4/28/2017)... Grants Pass, OR (PRWEB) , ... April 28, ... ... Adetutu Ijose, http://www.foodsthathealdaily.com , http://www.wiredlifesolutions.com , “Computers are everywhere and ... Kleyne Hour Power of Water, Global Climate Change and Your Health on Voice ...
(Date:4/28/2017)... ... April 28, 2017 , ... The Texas Cord Blood ... to the labor and delivery team at Women’s Hospital at Renaissance in Edinburg for ... birth at the hospital and decide to donate. , “Women’s Hospital at Renaissance ...
(Date:4/28/2017)... ... ... Pastor and Overseer at The House of Yahweh in Abilene, Texas, has published a new ... not. Yisrayl says with so many titles and names for the Creator, it’s hard ... a little Scripture, backed with a lot of research, the truth is undeniable. , ...
(Date:4/28/2017)... , ... April 28, 2017 , ... NuevaCare, a leading ... diverse as Millbrae, Burlingame, and Palo Alto, is proud to announce information upgrades to ... to bookmark and read organized content on topics such as home care (generally) as ...
Breaking Medicine News(10 mins):