Medical Product Compliance, Regulatory, Validation #top #biotech #companies #2013

Posted On Nov 15 2017 by

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …


Pharma compliance #drug #rep #jobs

Posted On Nov 15 2017 by

#pharma compliance # The Pharmaceutical Compliance Forum The Pharmaceutical Compliance Forum is a coalition of compliance professionals and legal counsel from almost 60 research-based pharmaceutical manufacturers. The members meet several times a year, focusing on open and informal sharing of compliance information, best practices, and current developments in the field. PCF also sponsors a three-day compliance congress each fall. Welcome PCF Leadership Here at PCF we are proud of our Leadership which is comprised of five senior compliance professionals. These six Co-Chairs plan the Spring and Fall Members Meetings and the multiple Pharma Congresses .View PCF Leadership information. 2017 Pharma …


Pharma Quality Systems and Compliance – NSF International #pharma #etf

Posted On Nov 8 2017 by

#pharma compliance # Pharma Biotech Pharma Quality Systems and Compliance Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Not addressing concerns highlighted in FDA 483s and FDA warning letters can potentially halt production or, worse, result in a recall, import bans, detention or product seizure, which can damage your organization s pipeline, financial well-being and reputation. With relentless, often subtle, changes to guidelines released by regulatory authorities around the world, it can be challenging to stay up to date. With substantial experience in creating, implementing, reviewing and remediating quality …


Guidance, Compliance, & Regulatory Information #pharmaceutical #companies #in #dallas #tx

Posted On Nov 8 2017 by

#pharma guidelines # Guidance, Compliance, & Regulatory Information Popular Items Affordable Care Act (ACA 6004) Information on Compounding Drug Compliance Programs Guidances (Drugs) Newly Added Guidance Documents Product-Specific Recommendations for Generic Drug Development Nicotine-Containing Products Notice to Industry: Postmarketing Requirements – Postmarket studies and clinical trials Office of Compliance The Office of Prescription Drug Promotion (OPDP) PLR Requirements for Prescribing Information Regulatory Guidance Drug Registration and Listing Sunscreen Innovation Act (SIA) Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Spotlight


Cryptainer SE Enterprise Encryption Software #cryptainerse, #cryptainer #se, #hipaa, #federal #security, #cryptography, #cryptography #algorithm, #encryption, #encryption #software, #command #line #processing, #file #encryption, #command #line, #omb #compliance, #pgp #encryption, #federal #security #solution, #command #line #encryption, #email #encryption, #data #encryption, #omb #encryption #software, #file #encryption #software, #blowfish #encryption, #encryption #programs, #email #encryption #software, #data #encryption #software, #encrypt, #hipaa #compliant #software, #encrypt #email, #encrypt #file, #encrypt #files, #data #encrypt, #encrypt #hard #drive, #hide #folders, #omb #data #encryption, #hipaa #security #software, #blowfish, #hipaa #tools, #cryptainer.

Posted On Sep 20 2017 by

# Cypherix®’s comprehensive corporate network security solution provides for a network wide encryption based security implementation, using the existing hardware and software infrastructure of the enterprise. It addresses vital security issues such as information security, command line processing, access control, and hierarchical dissemination of information, without any issues of data migration into the new structure. Cryptainer SE runs on any flavour of Windows. (Windows 95, Windows 98, Windows ME, Windows 2000, Windows 2003 Server, Windows XP, Windows Vista/Windows 7/Windows 8). ENTERPRISE SOLUTIONS Asymmetric key exchange protocols and private key servers. Compliant with international standards and protocols Interoperable with most commonly …


HIPAA Compliance Help, hipaa compliance date.#Hipaa # #compliance #date

Posted On Sep 13 2017 by

# Get Help with HIPAA Compliance Need assistance getting through a HIPAA Risk Assessment? Expresso – The Risk Assessment Express helps you complete your first HIPAA Risk Assessment in as little as three hours. We give you a “leg up” by automating the NIST seven step risk assessment process. The pre-populated list of threats, vulnerabilities, and business impacts that come with Expresso provide a huge time-savings advantage. Best of all, Expresso is fully customizable to fit your organization’s HIPAA Compliance Program. Watch the Expresso Demo Video to find out more. HIPAA Regulations Our HIPAA Regulations have super-handy contextual linking and …


Medical Product Compliance, Regulatory, Validation #forest #pharma

Posted On Sep 8 2017 by

#pharma tech # FRESH THINKING, BETTER OUTCOMES Your products touch lives. At Pharmatech Associates, we help life science companies bring these products to market worldwide. Navigating the complex and interconnected regulatory processes require technical expertise in compliance, product and process development, validation, and regulatory affairs. We call this the Pharmatech Ecosystem. And that means better outcomes for our clients’ patients. VALUE IN OUR PROCESS Our Subject Matter Experts have fully integrated development knowledge, hands on experience, and the ability to respond rapidly with pragmatic solutions, by applying proven and effective systems and practices. Our diligence in managing budget and timeline …


Pharma compliance #martindale #pharma

Posted On Sep 8 2017 by

#pharma compliance # The Pharmaceutical Compliance Forum The Pharmaceutical Compliance Forum is a coalition of compliance professionals and legal counsel from almost 60 research-based pharmaceutical manufacturers. The members meet several times a year, focusing on open and informal sharing of compliance information, best practices, and current developments in the field. PCF also sponsors a three-day compliance congress each fall. Welcome PCF Leadership Here at PCF we are proud of our Leadership which is comprised of five senior compliance professionals. These six Co-Chairs plan the Spring and Fall Members Meetings and the multiple Pharma Congresses .View PCF Leadership information. 2017 Pharma …


Pharma Quality Systems and Compliance – NSF International #cerulean #pharma

Posted On Sep 8 2017 by

#pharma compliance # Pharma Biotech Pharma Quality Systems and Compliance Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Not addressing concerns highlighted in FDA 483s and FDA warning letters can potentially halt production or, worse, result in a recall, import bans, detention or product seizure, which can damage your organization s pipeline, financial well-being and reputation. With relentless, often subtle, changes to guidelines released by regulatory authorities around the world, it can be challenging to stay up to date. With substantial experience in creating, implementing, reviewing and remediating quality …