Book Online Tickets for Comparability Protocols For Approved Dru, Palo Alto. This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substanc

Comparability Protocols For Approved Drugs

 

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    USD 249
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  • Group-Max 10 Attendees-Location

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    USD 629
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  • 1x Person - Unlimited viewing for 6 Months

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    USD 299
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  • One CD-USB is for usage in one location only

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    USD 399
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  • Live + Recorded Version

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    USD 429
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  • Live + Training CD-USB

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    USD 529
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About The Event

This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.

Why Should You Attend:

Attend this training to determine whether or not a comparability protocol will provide you with future advantage in product life-cycle management.

Areas Covered in the Webinar:

  • Is a comparability protocol required
  • When is a comparability protocol appropiate
  • What are the benefits of submitting a comparability protocol
  • What is the format and content
  • What is the timimg of submission
  • What is the format and content
 

Who Will Benefit:

This presentation s presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful to organizational positions and disciplines and at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing.

Professionals from the following disciplines will find the training highly beneficial:

  • Quality Assurance
  • Quality Control (Chem and Micro)
  • Process and Design Engineering
  • Process Automation
  • Manufacturing Operations
  • Validation
  • Regulatory Affairs

Instructor Profile:


Peggy Berry
Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.