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On Demand Documents
510(k) Submission and Clearance
How to Survive a DEA Inspection Series Pharmacy Records and Security
Best Practices for Establishing a Compliant Medical Device and Complaint Handling System
How to Survive a DEA Inspection Series - For Manufacturers and Distributors
510(k) Submission Contents and Format for Medical Devices

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  • Live Session
  • Recorded Session
Angela Bazigos
How to select Software for a Regulated Environment
Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Live Session Monday, June 3, 2013 10:00 AM PDT | 01:00 PM EDT , Duration:120 $243.00
Harry Huss
Risk Assessment
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. Even if one is not involved in doing the Risk Management, it would not hurt for them to understand something of what it is in case they observe something going wrong during the research.
Live Session Tuesday, June 4, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
David R Dills
Writing and Enforcing Effective SOPs
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done."
Live Session Thursday, June 6, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Mukesh Kumar
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
The first document FDA auditors review during the audit of a clinical site is the Trial Master File (TMF). The TMF is a collection of the essential documents to record a site has fulfilled its obligations to the sponsor regarding a clinical trial project.
Live Session Tuesday, June 11, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Jeff Schwegman
Lyophilization and Stabilization of Proteins, Cells and Viruses
This webinar will cover formulation and process development strategies for stabilizing biologically based pharmaceutical and diagnostic products including proteins, cells, and viruses (live, modified live, attenuated). Understanding the degradation mechanisms and improving stability of these molecules through formulation and processing techniques will be discussed in great detail in addition to covering some of the analytical techniques employed to verify the results.
Live Session Wednesday, June 12, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
Harry Huss
Business Continuity & Disaster Recovery
This is a course that anyone in a Pharmaceutical Company, CRO, hospital or clinic involved in clinical research should take.
Live Session Tuesday, June 18, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
David Lim
CE Marking: MDD, AIMDD and IVDD
This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
Live Session Wednesday, June 19, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
David R Dills
Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only apply to unapproved devices.
Live Session Thursday, June 20, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Jeff Schwegman
Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process
This seminar will cover the freezing, annealing, primary drying and secondary drying steps of a lyophilization process. As each of these steps can affect both the chemical and physical integrity of freeze-dried products, it is important to thoroughly understand the scientific principles behind each step, and how to apply them when developing an optimized lyophilization cycle. Additionally, understanding these principles and how then affect the product allows the development scientist to better troubleshoot failed products and or cycles.
Live Session Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:60 $243.00
Harry Huss
Hosting for Regulatory Inspections
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take. If they have never been involved they will learn what one is, if they have done clinical trials it will be useful to put everyone on the same level as far as terms and operations.
Live Session Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
Jeff Schwegman
Materials Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles
This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity). Understanding if a crystalline, amorphous, mixed, and or metastable system is present in our products, is critical in developing a sound, stable formulation that can easily be freeze-dried.
Live Session Wednesday, July 24, 2013 10:00 AM PDT | 01:00 PM EDT, Duration:90 $243.00
Dr. James R Harris
GMP Quality Principles

We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing, Processing, Packing, or Holding of Drugs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00
David Lim
Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)

This webinar is intended to discuss the requirements for medical device developers to meet the U.S. FDA's requirements on the 510(k).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00
David R Dills
Establish and Maintain an Effective Supplier Qualification Program

FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $288.00
Chinmoy Roy
21 CFR Part 11 Complying with: Step by Step

There is an increasing use of computers and electronic data in the pharmaceutical industry. Consequently, management of electronic records and data continues to be a concern of the regulators. CFR 21 Part 11 regulations were enacted in 1997 to address those concerns.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Casper E Uldriks
The Infamous Form FDA 483: How you respond can make or break you

The infamous Form FDA 483 (483) presents a list of observations noted by an FDA investigator, a consumer safety officer (CSO,) during the inspection of an establishment regulated by the FDA. The observations point out specific factual situations that in the investigator's view demonstrate an apparent violation of the applicable FDA regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
The Sunshine Act Reporting for Clinical Trials

Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Angela Bazigos
Project Management for Computer Systems Validation

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
FDA Inspection: Preparation and Management

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David R Dills
Draft Guidance for Device Industry and FDA - Postmarket Surveillance

This guidance document is being distributed for comment purposes only and will be of benefit for medical device manufacturers and the document was issued on August 16, 2011. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Schwegman
Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

This webinar will begin with a discussion of the physical properties of materials that are commonly used to formulate freeze-dried products, and the impact that these materials can have on how products freeze-dry (in regards to the physical and chemical integrity).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Chinmoy Roy
Bulletproofing your cGXP Documentation from Audit Citations

Regulators consider documentation to be a critical entity. Consequently, they always audit documentation systems and it is rare to find audits where 483s for poor documentation have not been issued.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David R Dills
FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides basic framework for computer systems used to generate records and data, and used for analysis and presentation.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Schwegman
Scale Up and Cycle Transfer for Lyophilization Cycles

This webinar will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. By using a methodical approach and understanding the thermal properties of a product, the scale-up or transfer process can be simplified and result in consistent product being produced in any freeze-dryer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Quality Management Systems for Medical Devices and IVDs

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…"
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
How to withstand an FDA audit of your facility

Learning how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Luis Chavarria
How FDA Inspection Observations are Reviewed for Regulatory Action

The presentation covers the different steps in processing observaions and evidence collected during an inspection for possible regulatory action.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Angela Bazigos
Current Concepts & Challenges in Cloud Compliance

Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Dr. James R Harris
GMP Vendor Audits

Description of a method to establish and conduct GMP audits of vendor facilities.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Angela Bazigos
The Hitchhiker's guide to 483s and Warning Letters

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Chris Doxey
A Practical Look at the Sarbanes - Oxley (SOX) Act of 2002

The legislation came into force in 2002 and introduced major changes to the regulation of financial practice and corporate governance. Named after Senator Paul Sarbanes and Representative Michael Oxley, who were its main architects, it also set a number of deadlines for compliance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Implementing Design control for Medical Devices and IVDs

Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Harry Huss
Computerized System Validation: Basic Concepts

The comprehensive testing and control of computerized systems if first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, "the system is down".
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Schwegman
Container – Closure Systems for Lyophilized Products

This webinar will cover various container closure systems used for freeze-dried products including vials and stoppers, bulk drying trays, and pre-filled syringes. Various aspects of the types of materials used, the specialized coatings available, and the configuration of the different systems will be discussed in relation to the impact on the products and the lyophilization process.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Howard T Cooper
Designing And Implementing The Quality System From Scratch

The opportunity to establish a new quality system from scratch has three potential results. The most rewarding is a cross-functional systems approach that balances quality activities to achieve product performance requirements and meeting internal and external customer requirements (needs & wants). The least desired outcome is a failed quality system that is so dysfunctional that it threatens the organization’s very existence.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
510(k): Format, Contents and Case Studies

This webinar is intended to demonstrate how to prepare a 510(k) in a manner to facilitate the review and for successful clearance.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Dr. James R Harris
Internal GMP Audits

This presentation provides a complete system for conducting internal GMP audits. It covers what to do and what not to do in performing internal audits for the purpose of assuring full compliance with the GMP regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Harry Huss
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency…both efficiency in project management, and avoidance of non-compliance penalties.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Dr. James R Harris
How To Conduct a Successful Process Validation

This presentation covers a methodology that can be used for any oral product process validation
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Schwegman
Optimized Formulation Development for Lyophilized Products

This webinar will cover the process and benefits of developing an optimized formulation for freeze-dried products to improve the quality and consistency of the product while also reducing the cycle time and associated costs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Best Practices for MDRs, Recalls, Corrections, and Removals

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Angela Bazigos
21 CFR 11 Compliance for Excel Spreadsheets

In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Chitra Edwin
Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

Clearly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization. SOP reviews are a high priority with auditors during an inspection. Poor quality, incomplete or non-existent SOPs are frequently a definite cause of a failed inspection.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Chinmoy Roy
Use GAMP to Surefire your CSV Audit

Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation. A third of recent warning letters have cited improper validation and/or incorrect or deficient implementation. After a walkthrough of regulations for CSV, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE’s GAMP V guide to include the V-model and ASTM’s E-2500 standards. Finally, the webinar addresses e-Validation and their impact on ensuring that Validation is no longer a costly and risky activity.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Luis Chavarria
FDA Investigations and Inspections

How FDA conducts investigations and inspections. Learn about the tools and procedures the FDA uses to conduct investigations and inspections from a former retired FDA Office of Regulatory Affairs officer.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
Critical SOPs for Clinical Sites

Clinical sites frequently struggle to understand FDA expectations regarding quality systems that should be in place to demonstrate compliance with good clinical practices. Experiences from FDA audits have shown that many clinical sites lack adequate systems and procedures for ensuring the good quality clinical trial conduct.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Chris Doxey
How to Implement a Risk Management Process

Risk management is the set of processes through which management identifies, analyzes, and, where necessary, responds appropriately to risks that might adversely affect realization of the organization's business objectives. The response to risks typically depends on their perceived gravity, and involves controlling, avoiding, accepting or transferring them to a third party.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Kasoff
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY!
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series: Controlled Substances and Hospitals

This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Improving 510(k) Submission Quality

This webinar is intended to present various strategies and methods to improve 510(k) submission quality. A 510(k) premarket notification submission (“510(k)”) is made to US FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Kasoff
Best Practices for Purchasing and Supplier Controls in the Medical Device Industry

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints

Medical device manufacturers, device user facilities, and applicable stakeholders are required to establish and maintain adequate procedures for handling complaints.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series: Due Diligences of a Pharmacy

The public media has been reporting the fraud and abuse of narcotic dispensed for pain. Reports target the legitimacy of prescriptions and pharmacist who fulfill them. Federal and state regulations have placed emphasis on corresponding responsibilities for the pharmacist who fulfills those prescriptions.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Ron Schoengold
Risk Management for Medical Devices: ISO 14971:2007

The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
Writing USFDA-acceptable Clinical Trial Protocols

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Dr Charles H Pierce
FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Jeff Schwegman
Lyophilization Process Development and Cycle Design

This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle to improve the quality and consistency of the product while also reducing the cycle time and associated costs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
510(k): How To Navigate Through Hurdles And Get It Cleared

This webinar is intended to demonstrate how to navigate through hurdles during 510(k) processes and get it cleared from FDA.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series - Law Enforcement and Pain Management

Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan. Also they will be familiarized with the necessary documentation that should be noted in the patient chart and step to prevent diversion of the dispensed or prescribed drugs.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Mukesh Kumar
IND Submission for a 505(b)(2) Product

A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. However, 505(b)(2) products require evidence from clinical trials conducted under an IND in support of the marketing approval application.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Dr Charles H Pierce
The Role of Lab Data in the Drug Development Process: Adverse Events and Subject Safety

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
510(k): Submission and Clearance

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series: Pharmacy Records and Security

The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Best Practices and FDA-Compliant Medical Device Reports (MDRs), Recall, Corrections and Removals

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series - For Manufacturers and Distributors

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
Best Practices for Establishing a Compliant Medical Device and Complaint Handling System

All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
Carlos M. Aquino
How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors

The training will cover several recommendations to improve the Corporate Due Diligence when narcotic drugs are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00
David Lim
510(k) Submission: Contents and Format for Medical Devices

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).
Recorded Session Access recorded sessions unlimited viewing for 6 months. $150.00

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