ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

  • Max Lazar
  • 23, May 2019 Thursday
  • 10:00 AM PDT | 01:00 PM EDT (60 Min)

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.

Live Online Training
May 23, Thursday 10:00 AM PDT | 01:00 PM EDT (60 Min)

$229.00
One Dial-in One Attendee
$599.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Recorded Version

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training
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Areas Covered in the Webinar:
  • 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.
Free Materials:
  • Program Slides
  • Electronic copy of FDA Q7 Guidance
Who Will Benefit:

Personnel responsible for

  • 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
Instructor Profile:
Max Lazar 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.

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. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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