Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.
In the absence of these guidelines, many organizations end up… Continue
Added by Joseph Wilcox on March 12, 2019 at 8:44am —
Number of candidates and delegate has doubt about the difference between NEBOSH and IOSH course which are mostly demanded by every organization to get job in occupational health and safety sector.
NEBOSH – National Examination Board for Occupational Health and Safety
It is an independent examination board, based on UK.… Continue
Added by Nakul Pratap on March 12, 2019 at 1:43am —
Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.
Added by Adam Fleming on March 11, 2019 at 8:57am —
If you have a colleague who gets down to hairsplitting detail at every work she undertakes, to the extent that she takes half a day to complete a task that can be done in half an hour, you have a person with OCD in your midst. Obsessive Compulsive Disorder is a psychological condition in which the person with it is too obsessed with perfection. This penchant for perfection in everything they do can be painstaking for others who interact with them, but for those with… Continue
Added by John Robinson on March 7, 2019 at 6:54am —
IOSH - Institution of Occupational Safety and Health. IOSH is a nonprofit organization based on UK with members throughout the world. It is one among the chartered body for occupational health and safety professionals with aim to enhance the health and safety standards and regulate the profession. This includes development, promotion of code of conduct and development, accreditation of health and safety… Continue
Added by Nakul Pratap on March 5, 2019 at 7:18am —
Fortune 500 companies and small family businesses alike share a business need - insuring that they have the talent necessary to effectively lead their organizations in the future. One of the most significant contributions a leader can make is insuring his/her business'continuity and sustainability - by having employees who are willing and capable of filling each key position with a plan for doing so when the need arises.
Succession Planning is a:
Added by John Robinson on March 5, 2019 at 6:59am —
Added by Pro-Sapien Software on March 5, 2019 at 6:41am —
NEBOSH International General Certificate in Chennai
The NEBOSH IGC in Chennai provides you the wide understanding of health and safety issues in a well -structured, regular class room course.
As one of the most widely taken health… Continue
Added by Nakul Pratap on March 4, 2019 at 6:53am —
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a 60-minute webinar on the topic, “Why & How do we Fail an FDA Inspection”. Vikram Kulshreshta, a Senior Management Professional with a strong experience in Quality Assurance & Regulatory Affairs, will be the speaker at this session. Please visit… Continue
Added by Joseph Wilcox on February 27, 2019 at 4:48am —
Traininng.com, a well-known provider of professional training for all the areas of regulatory compliance, will organize a 60-minute webinar on the topic, “The New EU Medical Device Regulation”, on February 21. Dr. Salma Michor, who is the founder and CEO of Michor Consulting Schweiz GmbH, who teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission, will be the speaker at this valuable… Continue
Added by Joseph Wilcox on February 25, 2019 at 6:49am —
Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable…
Added by Adam Fleming on February 21, 2019 at 7:40am —
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, will organize a webinar on the topic of HPLC Analytical Method Development and Validation, on February 21. John Fetzer, a senior professional in HPLC methods, will be the speaker at this session.
Please visit http://bit.ly/2SEmev3 to enroll for this webinar and gain insights into the core aspects of how to carry out… Continue
Added by Joseph Wilcox on February 21, 2019 at 6:14am —
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.
This course will also review… Continue
Added by Joseph Wilcox on February 20, 2019 at 6:33am —
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).
The Final Rule has been in effect since January 18, 2017. The…
Added by Adam Fleming on February 18, 2019 at 6:22am —
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.
Although each regulatory authority publishes guidelines and instructions regarding the requirements for the Entry Into Man (EIM) of a new… Continue
Added by Joseph Wilcox on February 18, 2019 at 5:20am —
If you want safety culture at your workplace, you should have certified safety consultant
A Safety consultant is the person who gives advices and aides the employees with respect to health and safety of both small and large size such as manufacturing factories, engineering, construction, mining and so on
Likewise the safety consultant guides you to rectify the solution for issues by enhancing the health and safety standards, policies as well as by limiting injuries and… Continue
Added by Nakul Pratap on February 15, 2019 at 7:29am —
Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.
Please visit http://bit.ly/2GFGiXr to enroll for this webinar.
A complaint says a lot about a product. It helps the… Continue
Added by Adam Fleming on February 15, 2019 at 6:54am —
Preliminary risk assessment (e.g., Likelihood X Impact) and the results of previous audits (e.g., number of NCs) are often used to help prioritize the audit schedule. While these are worthwhile to consider, they do not necessarily reflect the real-time performance of the processes that could be included in the audit plan. This means many audits are likely investing time and human resources in looking at processes that are performing adequately, while others that might be at greater risk are… Continue
Added by Joseph Wilcox on February 13, 2019 at 6:13am —
Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Tax Evasion and Tax Fraud. What it means to you when monitoring BSA and filing SARs”.
Doug Keipper, a Certified Anti-Money Laundering Specialist (CAMS) and a former Bank Secrecy Act officer and compliance officer, will be the speaker at this webinar. Please visit… Continue
Added by Joseph Wilcox on February 6, 2019 at 6:33am —
Fire safety measurements and guidelines at the workplace: Continue
Fire at the workplace is the most devastating hazard for both the public and workers. As it leads to lite to serious injuries or sometimes even fatalities along with the great loss in property. So fire safety is quite important and makes sure that…
Added by HrishikeshRam on February 5, 2019 at 5:12am —