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Ref : 30199
Event :ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

Date :Thursday August 15th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

In this webinar attendees will learn the background of all sections of ICH Q7 guidance, key critical section contents, the authors intent when writing critical parts of this guidance and how to apply Q7 in an Active Pharmaceutical Ingredient (API) facility.
 

Program

  • Why was there a need to write API GMP even though Drug Product GMP (21 CFR Part 210 and 211) already existed?
  • What caused ICH to take action?
  • How was this need address initially and finally?
  • Who participated and why?
  • Identify Sections of Q7
  • Discuss KEY Sections
  • Examine important parts of Key Sections
  • Discuss how to apply Q7
  • Opportunity to ask specific questions about Q7 that is not obvious in this oversite webinar.

Speakers

Max Lazar
Owner, FDA Regulatory Compliance Consulting

Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years. At that time, he was Vice President, FDA & DEA Compliance reporting to the firm’s President. Over his career, he progressed from a QC bench chemist through increasing titles and responsibilities, reaching his ultimate responsibility for Compliance oversight of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, and Fine Chemicals and Vitamins. Following his retirement, he was approached to establish a consulting business specializing in API GMP issues and the training of personnel in both API and other drug related GMP.

His more than 50-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He represented USA industry at the PIC/S Canberra Australia Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing API industry related regulatory issues. He was one of five invited industry representatives at the WHO/CDC/FDA Diethylene Glycol Contamination Prevention Workshop that followed the Haitian tragedy where almost 100 children died. This workshop developed recommendations for consideration by the Pan American Health Organization and WHO. Max was named as PhRMA’s representative on the FDA PQRI initiative that developed the initial Bulk Substance projects and is a current member of existing USP water panels.For his contribution to Q7A, he was awarded the USA FDA Commissioner’s Special Citation “For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products.”

 

He is a member of numerous professional organizations. He has been on the Editorial Board of the Journal of GXP Compliance, the Editorial Advisory Board of Pharmaceutical Outsourcing and the Advisory Board of the GMP Manual, Maas & Peither AG – GMP Publishing. Max is listed in numerous editions of Who’s Who including Who’s Who in America and is a graduate of Brooklyn College of the City University of New York.

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent Pharmacy
ich q7 guidelines, ich q7 training, active pharmaceutical ingredient gmp, ich q7, fda q7 guidance, gmp compliance, active pharmaceutical ingredients
Professionals, Producing, Testing, Storing or distributing API Drug intermediates, Excipients, Developing, Or registration of these with FDA. Managers, Site managers, Production, Quality, Development, Maintenance, Storage/Distribution Management of API Firms. Repacker or Relabelers of API
10 -- --
English

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