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Max Lazar
Instructor Max Lazar
Product Id 600557
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Outsourcing or Purchasing API or Excipients – Key Steps

Overview:

This Webinar is designed to focus the participants on issues that are broader than the classical GMP Audit practices that need to be addressed during any relationship that is being established between various parties - the contractor giver and the contact acceptor or the purchaser and the supplier.

In addition to examining the more important GMP concepts that should be satisfied in establishing a commercial relationship that is associated with pharmaceutical based supply issues, the program will examine some of the more important non-GMP issues associated with product risk and safety associated with importing of API and excipients into the USA. What can you depend upon from the FDA for your safety net and what must you assume is to be self-driven by you? What should you delegate to others and what should you do for yourself? Is it safe or even appropriate to rely upon paper reviews/audits? What risks exist for you and how can you minimize them? Can you ever eliminate 3rd party risks? At what point are risks reasonable to assume?

Why you should attend: When one considers outsourcing an internally produced material or purchasing from external suppliers, where should you focus your efforts? What is important to your business success from a business, quality and safety perspective? Purchasing materials can be a mine field of risks which need careful consideration to protect you from quality and safety pitfalls. Purchasing materials or services from a local supplier can be a totally different experience from sourcing your API, excipients or materials from foreign locations. Even the FDA is becoming frustrated with problems that are being encountered by the growing international economy. If you are a member of the pharmaceutical industry that is caught in the middle of this challenge, you may benefit from this webinar as the presenter discusses steps to take to reduce your risks and exposure to this growing "combat zone".

Areas Covered in the Session:

  • FDA Current position
  • What to look for when selecting a supplier
  • What risks are possible
  • What risks are not reasonable?
  • What do you need to do to establish a sound supplier relationship?
  • Verify your systems and their supplier systems
  • Measure the suppliers reliability and sources
  • Establish an historical review.
  • Do you know enough about the supplier to truly evaluate your risks?
Who Will Benefit:
  • Manufacturing managers and supervisors
  • Quality Control and Quality Assurance Managers and Supervisors
  • Chemical Engineers responsible for manufacturing of API / Excipients
  • Materials Managements personnel such as purchasing agents and management
  • R&D Management for product sourcing

Speaker Profile
Max Lazar retired from Hoffmann-La Roche Inc. in 2001 after 35 years, where he was Vice President, FDA & DEA Compliance. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance as well as the Excipient GMP (IPEC) Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG’s intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself.

His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharmaceutical Manufacturers Association’s Bulk Pharmaceutical Committee of the Quality Control Section. This chair lasted thru the reorganization of PMA into PhRMA and until Max’s retirement in 2001. He has presented at numerous meetings and training programs including SOCMA, PDA, DIA, PhRMA, Barnett, and IIR both domestically and overseas.
,br> Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association’s (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference which preceded the ICH API activities and worked with FDA during the 1980 – 2000 era addressing all of the API industry related regulatory issues including the 1987 NDA Re-Write Guidelines and GMP activities. 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.

He was Vice Chair of the USP Pharmaceutical Waters Expert Committee (2000-2005) and had been re-elected to another 5-year term (2005-2010) as a member on this USP Expert committee. In 2011, USP has appointed Max to three USP Expert Panels covering various Water Subjects of interest to USP. Max conducts training and consultations on API GMP (ICH Q7A) and other FDA Compliance issues. While specializing in API, Max’s experience provides him with expertise in many areas of FDA compliance including Excipients, laboratory, documentation, sterile and oral dosage forms as well as devices, diagnostics and radiopharmaceuticals.

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 is 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. He has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups. He resides in Surprise, AZ.

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