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Upcoming Events

ComplianceOnline

Expense Reporting Best Practices

New York, NY
With companies everywhere eyeing the bottom line, insistence on compliance with travel & entertainment policy is becoming more commonplace. What's more, the IRS has also been taking an equally harsh stance, so compliance m... read more

Biocompatibility Testing for Medical Devices

Boston, MA
The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more succ... read more

Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues

Houston, TX
This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. A... read more

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

Boston, MA
The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used cor... read more

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Boston, MA
Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombin... read more

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH

Boston, MA
Analytical methods should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the me... read more

Drug Master Files (DMF) - Translating FDA Guidances into Usable Documentation

San Diego, CA
The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining ... read more

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

Irvine, CA
This Seminar will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide few examples of FDA approved use of stem cells in medicine and wha... read more

Packaging and Labeling in Pharmaceutical Production

Boston, MA
Seminar to help you understand compliant packaging and labeling process in the larger product development from conception of a product to its realization and distribution. Get equipped to reduce cycle time, avoid costly er... read more

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

San Francisco, CA
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with t... read more

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

SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Philadelphia, PA
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consiste... read more

Aseptic Processing Overview and Validation

Houston, TX
This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer

San Francisco, CA
While the HIPAA rules have been in place for years now, the focus of their application has recently changed as technologies and practices have changed, and changes to the rules are also on the horizon. In addition, there a... read more

Employment Laws Certificate Program

Greenville, SC
If you supervise at least one employee you need to be knowledgeable with Employment Laws in order to avoid costly lawsuits, judgements, settlements and to reduce employee complaints and claims. The amount of discrimination... read more

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Tampa, FL
The globalization of the pharmaceutical supply chain has led increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particular... read more

Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error

Boston, MA
Dr. Ginette Collazo — a 20-year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more — will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing e... read more

Clinical Data Management (FDA E6 GCP Guidelines)

Irvine, CA
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

San Francisco, CA
This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on bot... read more

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

Newark, NJ
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency fo... read more

Quality Control Laboratory Compliance - cGMPs and GLPs

Philadelphia, PA
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biolog... read more

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 manufa... read more

Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan

San Francisco, CA
Performing a corporate wide Risk Assessment can seem like a daunting task for an organization. In reality, it can be done using a template and brainstorming with internal auditors, certified fraud examiners and business un... read more

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 ca... read more

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 w... read more

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 ... read more

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 committe... read more

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 reportin... read more

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 t... read more

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... read more

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 observati... 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

Managing Your FDA Inspection: Before, During and After

Managing Your FDA Inspection: Before, During and After

San Francisco, CA
FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The sca...
Thu, Jun 20 2019 8:30 AM Fri, Jun 21 2019 4:30 PM

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)

San Diego, CA
Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the comin...
Thu, Jun 20 2019 8:30 AM Fri, Jun 21 2019 4:30 PM

Root Cause Analysis and CAPA using 8-D Problem Solving Method

Root Cause Analysis and CAPA using 8-D Problem Solving Method

Huntsville, AL
Errors and defects are a problem in virtually every industry. The goal of defect-free/error-free product or service delivery is the aim of every company. However, in order to eliminate defects or errors permanently, you must use a disciplined approach in order to ensure that the problem does not ...
Thu, Jun 20 2019 8:30 AM Fri, Jun 21 2019 4:30 PM

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting

Philadelphia, PA
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn h...
Thu, Jun 20 2019 8:30 AM Fri, Jun 21 2019 4:30 PM

Designing and Sustaining New and Existing Product Stability Testing Program

Designing and Sustaining New and Existing Product Stability Testing Program

Atlanta, GA
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made ...
Thu, Jun 20 2019 8:00 AM Fri, Jun 21 2019 5:00 PM

FDA's New Import Program for 2019 - Strict Precision

FDA's New Import Program for 2019 - Strict Precision

San Francisco, CA
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these p...
Tue, Jun 18 2019 8:30 AM Wed, Jun 19 2019 4:00 PM

21 CFR Part 11 Compliance for SaaS/Cloud Applications

21 CFR Part 11 Compliance for SaaS/Cloud Applications

San Diego, CA
Learning Objectives: Reduce costs, usually by two-thirds, for compliance with electronic records Learn how to use electronic records and electronic signatures to maximize productivity Understand what is expected in Part 11 and Annex 11 inspections so you are prepared Avoid 483 and Warning Letter...
Thu, Jun 13 2019 8:00 AM Fri, Jun 14 2019 3:30 PM

CA HR 101 - HR Generalists and CA Supervisors Too

CA HR 101 - HR Generalists and CA Supervisors Too

San Francisco, CA
If both the Supervisors and HR don’t administer an employer’s accountabilities in the correct manner what could have been solved as a mere miscommunication, can quickly turn into a costly lawsuit. It is not just compliance risk management that is important. Just as important is that Supervisors ...
Thu, Jun 13 2019 8:00 AM Fri, Jun 14 2019 4:30 PM

REACH and RoHS Compliance: Gain a Deeper Understanding

REACH and RoHS Compliance: Gain a Deeper Understanding

Houston, TX
This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and will draw out key developments and key dates (if applicabl...
Thu, Jun 13 2019 8:30 AM Fri, Jun 14 2019 4:00 PM

Statistical Process and Quality Control

Statistical Process and Quality Control

Chicago, IL
This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased...
Thu, Jun 13 2019 8:30 AM Fri, Jun 14 2019 4:30 PM
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