DEA, Your Registration and How to Lose It

webinar-speaker   Carlos M Aquino

webinar-time   120 Min

Product Id: 701992

This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals 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.

20 / Sep / 2021 - Monday

* Per Attendee $299

 

Root Cause Analysis - The Heart of Corrective Action

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 703391

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

22 / Sep / 2021 - Wednesday

* Per Attendee $199

 

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703831

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

24 / Sep / 2021 - Friday

* Per Attendee $199

 

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   120 Min

Product Id: 702317

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

4 / Oct / 2021 - Monday

* Per Attendee $299

 

How to write SOP's that Avoid Human Error

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704418

This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.

5 / Oct / 2021 - Tuesday

* Per Attendee $199

 

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   60 Min

Product Id: 705497

This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.

7 / Oct / 2021 - Thursday

* Per Attendee $199

 

How to Conduct Successful Supplier Audits

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704499

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

18 / Oct / 2021 - Monday

* Per Attendee $199

 

The Importance of Packaging and Labeling in Pharmaceutical Product Development

webinar-speaker   Michael Esposito

webinar-time   60 Min

Product Id: 706063

Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

18 / Oct / 2021 - Monday

* Per Attendee $199

 

Troubleshooting Dissolution Methods for Solid Oral Dosage Forms

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706599

The root cause of variable or inconsistent data from compendial dissolution tests can be difficult to identify. Formulation, equipment, operator error and incorrect calculation may be factors. This webinar presents a systematic, logical approach to investigating anomalous dissolution results.

18 / Oct / 2021 - Monday

* Per Attendee $229

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

20 / Oct / 2021 - Wednesday

* Per Attendee $199

 

Introduction to European Good Pharmacovigilance Practices: 4-hr Virtual Seminar

webinar-speaker   Miranda Dollen

webinar-time   4 Hrs

Product Id: 706466

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide a robust introduction to Good Pharmacovigilance Practice (GVP) in the European Economic Area, reviewing all modules of the Guidelines on GVP published by the European Medicines Agency.

4 / Nov / 2021 - Thursday

* Per Attendee $399

 

How to Implement the FDA SUPAC Guidance

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704312

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

18 / Nov / 2021 - Thursday

* Per Attendee $199

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Recording Available

* Per Attendee $349

 

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704314

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

Recording Available

* Per Attendee $299

 

Handling OOS Test Results and Completing Robust Investigations

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 704351

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Recording Available

* Per Attendee $299

 

Best Practices for an Effective Cleaning Validation Program

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 704329

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

Recording Available

* Per Attendee $299

 

How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy

webinar-speaker   Carlos M Aquino

webinar-time   120 Min

Product Id: 701991

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.

Recording Available

* Per Attendee $349

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Recording Available

* Per Attendee $279

 

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

webinar-speaker   Ginette M Collazo

webinar-time   60 Min

Product Id: 704210

This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.

Recording Available

* Per Attendee $299

 

 

 

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