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Search Results - FDA rules

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Showing 1 to 25 of 27 Articles matching 'FDA rules' in related articles.
Pages: 1 | 2 | Next >>

1. Activities involved in Computer Systems Validation
June 06, 2016

Computer Systems Validation (CSV) is central to the life sciences industry. Apart from being a regulatory requirement as set out by various regulatory authorities and practices such as the FDA, EMA, GCP, GLP, GMP and all the Predicate Rules; CSV is also very important to implement because not doing so will result in costly consequences. These can range from: More than anything else, implementation of CSV is also important because it ensures that the data is accurate and the information, secure. Implementing Computer Systems Validation is also an important step in making sure that t... (read more)

Author: John Robinson

2. Seminar on The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules
February 03, 2015

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and s... (read more)

Author: John Robinson

3. 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems a
July 27, 2014

The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Complia... (read more)

Author: John Robinson

4. Live Seminar: Advertising and Promotional Requirements for Drugs and Medical Devices by David R. D
July 27, 2014

Overview: The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated... (read more)

Author: John Robinson

5. 2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems a
May 20, 2014

The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance ... (read more)

Author: John Robinson

6. seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules
May 20, 2014

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and secur... (read more)

Author: John Robinson

7. 2-day In-person Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems at Zurich,
April 02, 2014

The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV ... (read more)

Author: John Robinson

8. 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Co
March 04, 2014

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and secur... (read more)

Author: John Robinson

9. Computer systems validation (CSV) need to avoid 483's/Warning Letters
February 25, 2014

Those in computer systems validation (CSV) need to avoid 483’s/Warning Letters One of the prime requirements for those in CSV, also known as Software Validation, apart from coming out with quality output, is avoiding 483’s/Warning Letters from the FDA. Computer Systems Validation (CSV) being a prime element of the Life Sciences Industry; is bound by all the predicate rules, as well as 21 CFR 11 and Annex 11. Of these, Annex 11 impacts all areas of ICH Q9 and ICH Q10. This is the basis to avoiding 483’s/Warning Letters from the FDA. Knowledge of how to implement CSV is very important... (read more)

Author: John Robinson

10. 2-day In-person Seminar on Computer System Validation - Reduce Costs and Avoid 483s at Los Angeles
January 28, 2014

Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. The latter impact all areas of ICH Q9 and ICH Q10. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequen... (read more)

Author: John Robinson

11. 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules at
January 28, 2014

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and s... (read more)

Author: John Robinson

12. 2-day In-person seminar on Mastering the HIPAA Privacy, Security, and Breach Notification Rules at
January 28, 2014

Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and s... (read more)

Author: John Robinson

13. 2-day In-person seminar on Computer System Validation - Reduce Costs and Avoid 483s At Chicago IL
January 08, 2014

Overview: The Problem: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. The latter impact all areas of ICH Q9 and ICH Q10. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. ... (read more)

Author: John Robinson

14. 2-day In-person Seminar on Why is FDA at my Facility, and What do I do During an Inspection at Sing
January 08, 2014

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc.... (read more)

Author: John Robinson

15. 2-day In-person Seminar on Why is FDA at my Facility, and What do I do During an Inspection at Duba
January 08, 2014

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc.... (read more)

Author: John Robinson

16. FDA Rules on Colored Contact Lenses
November 15, 2013

Contact lens wearers need to know the guidelines from the Food and Drug Administration about contact lenses. Pay attention to recommendations from qualified eye doctors. If you choose to acquire the affordable contact lenses, make sure that you have an updated and valid prescription. It should be a prescription that was given by a licensed eye doctor not more than one month ago. This is necessary particularly if you have a chronic eye ailment. Prescriptions are still considered valid after a month but if you know there have been changes with your vision, you need to see an eye care professio... (read more)

Author: Earl White

17. Auditing Analytical Laboratories for FDA Compliance - Webinar by GlobalCompliancePanel
October 23, 2013

Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of d... (read more)

Author: charles ben

18. Unique Device Identification (UDI) Final Rules Overview
October 08, 2013

Scheduled On : Wednesday, November 6, 2013 at 1:00 PM EDT Duration : 60 Minutes This webinar is recorded. Description : This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013. This webinar is further intended to help you effectively implement a unique device identification (UDI) system (UDI system). In particular, new changes in the final rules will be discussed, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant... (read more)

Author: Anita Anzo

19. Federal judge rules fda should act on animal antibiotics - China Digital Keypad Door Lock
September 28, 2013

NEW YORK (AP) - A federal judge has ordered the Food and DrugAdministration to evaluate the safety risks to human healthassociated with the widespread use of antibiotics in food-producinganimals, saying the agency has done "shockingly little" sinceproposing in the 1970s to order a substantial reduction in the useof antibiotics in animal feed. U.S. Magistrate Judge Theodore Katz in Manhattan issued the orderin a ruling filed on Monday. The decision largely agreed with thearguments of several health and consumer organizations that suedlast year, saying the FDA violated federal law by failin... (read more)

Author: grass lawn

20. FDA Regulation of Medical Devices : Rules, Expectations and Needed Submissions - Webinar by GlobalC
September 24, 2013

Overview: This 60-minute Medical Device webcast is focused on the requirements of the US FDA Premarket Notification (510(k) and Premarket Approval (PMA) processes. Designed to provide an understanding of the FDA expectations for information to be in place and submitted for medical devices requiring either a 510(k) submission or a premarket application (PMA), and clarify when each type of submission is appropriate, this webcast will be useful for everyone involved in developing and bringing to market a medical device, whether in management, production, quality, regulatory affairs or marke... (read more)

Author: charles ben

21. Organic Industry Watchdog: FDA Food Safety Rules Threaten to Crush the Good Food Movement
September 19, 2013

September 19, 2013 FOR IMMEDIATE RELEASE Contact: Mark Kastel, 608-625-2042 Organic Industry Watchdog: FDA Food Safety Rules Threaten to Crush the Good Food Movement New Report Suggests Proposed Rules Could Drive the Nation's Safest and Best Farmers Out of Business http://www.cornucopia.org/2013/09/fda-food-safety-rules-threaten-crush-good-food-movement/ CORNUCOPIA, WI: After years of deliberation in Congress, interagency meetings, lobbyist activity, and a never-ending stream of food poisoning outbreaks, the Food and Drug Administration (FDA) is finally poised to implem... (read more)

Author: Cornucopia Institute

22. 2-day In-person Seminar on "Surviving an FDA Inspection: Understand the Do's and Don'ts and the Gro
September 06, 2013

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc.... (read more)

Author: charles ben

23. Food Traceability and a Reason for Implementation
September 01, 2013

A bill recently proposed food security aims at reducing the number of injuries caused by food contamination. How it will affect the food industry? Food tracking One of the most exciting aspects of the controversial bill is the traceability requirements of the retail food manufacturer from the original source - the product. And manufacturers and suppliers to know where the food came from each element, and wherever you can. These rules come after a series of food contamination events in 2009 and 2010, because the FDA had difficulty finding the source of the salmonella contamination. Months... (read more)

Author: Jonathan Smith

24. Medicine of Atorvastatin Calcium!
August 28, 2013

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Atorvastatin Calcium monograph to accommodate generic products recently approved by the FDA. The changes listed below were previously published on the USP Pending Monographs website as a part of the Authorized Pending Monograph. Additionally, changes were made to allow the use of a suitable antioxidant. Additional forms of the drug substance, namely an amorphous form, semicrystalline form, and the propylene glycol solvate form of atorvastatin c... (read more)

Author: yang W

25. Dietary Supplement Advertising, Claims, and Avoiding Trouble - Webinar by GlobalCompliancePanel
August 21, 2013

Overview: The webinar will review U.S. dietary supplement regulations and help assure that dietary supplement companies and marketers understand the regulations and advertise their products in compliance with FDA and FTC rules. It will help dietary supplement manufacturers and distributors market their products properly and avoid Warning letters and enforcement actions related to claims that violate dietary supplement regulations. Why should you attend: The FDA and the FTC have been enforcing regulations and cracking down on illegal dietary supplement advertising and claims in rec... (read more)

Author: charles ben

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