WEBINARS

 

Drug Development Regulatory Compliance Training - Live Webinars, Recordings & CDs

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

 

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

 

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.

29 / Nov / 2021 - Monday

* 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

 

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

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Recording Available

* Per Attendee $349

 

Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers

webinar-speaker   Meena Chettiar

webinar-time   60 Min

Product Id: 705401

This webinar will explain the quality system regulations (QSR) for combination device manufacturers to ensure compliance with for FDA and ISO 13485 requirements. It will also provide practical tips to sustain the growth of your quality system in the long run.

Recording Available

* Per Attendee $349

 

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

webinar-speaker   Vanessa Lopez

webinar-time   90 Min

Product Id: 704758

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

Recording Available

* Per Attendee $299

 

Validation of HPLC/UPLC Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705291

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Recording Available

* Per Attendee $249

 

Sterilization of Pharmaceutical Products and Medical Devices

webinar-speaker   Carl Patterson

webinar-time   90 Min

Product Id: 705310

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

Recording Available

* Per Attendee $299

 

Process Capability Analysis, and What to Do if it's Not a Bell Curve

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 705157

This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.

Recording Available

* Per Attendee $229

 

Understanding and Implementing a Technology Transfer Process

webinar-speaker   Steven Laurenz

webinar-time   60 Min

Product Id: 705031

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

Recording Available

* Per Attendee $299

 

Understanding and Implementing a Quality by Design (QbD) Program

webinar-speaker   Steven Laurenz

webinar-time   60 Min

Product Id: 705001

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

Recording Available

* Per Attendee $299

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Recording Available

* Per Attendee $299

 

Technical Writing for Medical Products: SOPs, Investigations and Change Records

webinar-speaker   Regina Fullin

webinar-time   60 Min

Product Id: 704304

In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.

Recording Available

* Per Attendee $299

 

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

webinar-speaker   Saeed Qureshi

webinar-time   120 Min

Product Id: 705271

This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.

Recording Available

 

ASTM 2500: Lessons Learned Through a Decade of Implementation

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 705911

This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.

Recording Available

 

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.

Recording Available

* Per Attendee $249

 

Stability Programs for Leachable Impurities

webinar-speaker   Wayland Rushing

webinar-time   60 Min

Product Id: 704685

This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

Recording Available

* Per Attendee $249

 

 

 

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