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Upcoming Events

ComplianceOnline

Project Management for Human Resources

San Diego, CA
HR Managers are asked to juggle a wide variety of assignments and add on special ones as needed. In many companies, the people, who formerly performed specialized tasks, are gone, along with their expertise. The work still... read more

Analytical Instrument Qualification and System Validation

Boston, MA
Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR P... read more

Why is FDA at my facility, and what do I do during an inspection?

Boston, MA
This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respo... read more

Implementing an Effective Regulatory and Policy Change Management Process

Philadelphia, PA
In this two day workshop we will review regulatory compliance requirements and Policy Management. The course will focus on the design of the risk management, standard operating procedures (SOPs) and entities subject to cor... read more
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Past Events

Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11

Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11

San Diego, CA
The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity ...
Mon, Sep 16 2019 8:30 AM Tue, Sep 17 2019 4:30 PM

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Boston, MA
Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such m...
Mon, Sep 16 2019 8:30 AM Tue, Sep 17 2019 4:00 PM

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Ins

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Ins

San Diego, CA
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas. By attending this seminar, you will discover: How to overcome...
Thu, Sep 12 2019 8:30 AM Fri, Sep 13 2019 5:00 PM

Detecting and Preventing Internal and External Fraud

Detecting and Preventing Internal and External Fraud

Raleigh, NC
Organizations of all kinds and sizes are increasingly threatened by fraud. Embezzlement, kickbacks, check fraud, financial statement fraud and vendor billing schemes are just a few of the countless economic crimes committed by employees and outsiders. This two day interactive in-person seminar w...
Mon, Sep 9 2019 8:30 AM Tue, Sep 10 2019 4:30 PM

Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry

Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry

Boston, MA
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed w...
Mon, Sep 9 2019 8:30 AM Tue, Sep 10 2019 4:30 PM

Biostatistics for the Non-Statistician

Biostatistics for the Non-Statistician

Boston, MA
Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical soft...
Thu, Sep 5 2019 8:30 AM Fri, Sep 6 2019 4:30 PM

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

Philadelphia, PA
Why You Should Attend: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other coun...
Thu, Aug 29 2019 8:30 AM Fri, Aug 30 2019 4:30 PM

FMLA, ADA and PDA Certificate Program

FMLA, ADA and PDA Certificate Program

Greenville, SC
Join us In-Person in Greenville, SC or Online via Live Stream / Webinar for our Instructor-Led 2-Day In-Person FMLA, ADA and PDA Certificate Program. This is a thorough Certificate Program Training which will provide you with the tools and resources you need to maintain compliance with these thre...
Mon, Aug 26 2019 10:00 AM Tue, Aug 27 2019 6:00 PM

GMP Compliance for Quality Control and Contract Laboratories

GMP Compliance for Quality Control and Contract Laboratories

Philadelphia, PA
This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documen...
Mon, Aug 19 2019 8:30 AM Tue, Aug 20 2019 4:30 PM

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

San Francisco, CA
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing...
Thu, Aug 15 2019 8:30 AM Fri, Aug 16 2019 4:00 PM
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