Making API GMP work for YOU and Your Company!

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• Making API GMP work for YOU and Your Company!

GMP
www.onlinecompliancepanel.com 510-857-5896
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• Instructor 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, RD, 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
  international standard, Max is uniquely qualified
  to share and explain the EWGs intent of this new
  guidance.His almost 50-year career in the
  Pharmaceutical Industry includes numerous
  memberships and chairs of committees.

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• Description
• GMP compliance, a fundamental
  requirement of Federal Drug Law, applies to
  various products that are subject to the US FD
  C Act. Under this US law, Active Pharmaceutical
  ingredients (API) are subject to this Act's
  requirements. Historically, many organizations
  looked at CGMP as a mandated cost and not as an
  opportunity to improve a business.
• What this program will examine
  is how this legal requirement can, if properly
  executed, actually result in a significant
  business benefit to companies. How one applies
  the GMP's intent and requirements within a firm's
  GMP functions and organizations can actually
  yield a value added activity.

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• Why Should you Attend
• If you or your company is subject
  to Drug GMP, then you can benefit from this
  Webinar. Whether you produce API or Drug
  products, you will potentially be able to profit
  from the instructor's almost 50 years of
  experience in the manufacturing and testing of
  drugs under the umbrella of GMP. Understanding
  the drug guidance and/or regulations that have
  applied to API and drug products is important to
  the bottom line impact of GMP.
• Understanding the rules of
  the game will make you a better and a more
  effective member of your firm's team. Learn what
  you need to implement and require when
  establishing practices and procedures. We will
  discuss the impact of proper CGMP practices
  verses the impact of inappropriate activities and
  actions.

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• Who can Benefit
• Firms that are subject to CGMP requirements.
  Doesn't really matter if you produce API or other
  drug products.
• Quality Control and any Quality Unit personnel
• Engineering and Production Management
• Management that thinks Quality units negatively
  impact the firm's income
• Purchasing and materials management personnel
  that believes that quality control is increasing
  their company's expenses
• Distribution personnel
• RD personnel responsible for methods and
  procedures that will be used by API functions
• Regulatory Affairs personnel responsible for
  filing DMF, NDA, ANDA and another FDA related
  filings and registrations.

www.onlinecompliancepanel.com 510-857-5896
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• Objectives of the Presentation
• Establishing the right Corporate and Operating
  Quality Policy
• Define expectations of your policies and
  procedures
• Why is follow-up action important?
• Why is proper communication important between
  internal groups?
• What are the systems you need to define as
  critical?
• Why tracking trends can be invaluable?

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf formate will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Get certification of attendance.

• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf formate will be
  mailed to you
• Get certification of attendance.

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com