WEBINARS

 

Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

 

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

 

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

20 / Oct / 2021 - Wednesday

* Per Attendee $249

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

21 / Oct / 2021 - Thursday

* Per Attendee $199

 

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704885

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

27 / Oct / 2021 - Wednesday

* Per Attendee $229

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

27 / Oct / 2021 - Wednesday

* Per Attendee $199

 

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 702540

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

3 / Nov / 2021 - Wednesday

* Per Attendee $249

 

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704659

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

8 / Nov / 2021 - Monday

* Per Attendee $199

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   75 Min

Product Id: 701582

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

18 / Nov / 2021 - Thursday

* Per Attendee $229

 

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

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

9 / Dec / 2021 - Thursday

* Per Attendee $229

 

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.

Recording Available

* Per Attendee $299

 

Report Writing for Auditing Professionals

webinar-speaker   Phil Vassallo

webinar-time   90 Min

Product Id: 703814

Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $299

 

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.

Recording Available

* Per Attendee $349

 

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

 

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701432

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

Recording Available

* Per Attendee $299

 

 

 

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