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VERSION:2.0
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BEGIN:VEVENT
DTSTAMP:20240329T155341Z
UID:92015e94-52f1-421a-8511-0a6eb9ca5caf
DTSTART:20211005T090000
DTEND:20211006T090000
CLASS:PRIVATE
DESCRIPTION:
This ICH GMP 2-Day seminar will provide your company the opp
ortunity for comprehensive understanding of ICH GMP and the nuances and di
fferences between the three main ICH triumvirate regions (U.S. EU and Japa
n). It will cover the key areas of how ICH was established\, it'\;s goa
ls and objectives\, expectations of the healthcare authorities involved an
d practical differences that you will experience in a GMP inspection of a
facility by FDA\, an EU Competent Authority or PMDA.
\nThe seminar will
discuss in detail the:\n\n\n - Types of inspections done by US FDA\
, EMA and PMDA
\n - Typical Audit Agenda that can be expected by eac
h Authority
\n - Scope of Audits.........how many auditors\, how man
y days
\n - When audits will likely occur
\n - The expectation
differences between inspections of API and Finished Product facilities\n
- What areas of GMP become a focus by region
\n - Typical aud
it observations by region [by Healthcare Authority]
\n - Getting rea
dy / preparation / self-inspection / mock audits
\n - Managing the A
udit.......the Importance of the QA Audit Generalist
\n - Importance
of SMEs [subject matter experts]
\n - Processes &\; timelines\n
- Acknowledging previous Healthcare Authority Audits.......when is
it possible?
\n - Examples of unique experiences encountered during
audits
\n
\n\n
\nWho will benefit:
\nThis Seminar wil
l provide invaluable assistance to all License Holder personnel in the Pha
rmaceutical\, Biotechnology and Combination Products areas\, including con
tract manufacturers\, packagers and suppliers. Particular functional exper
tise receiving value from attending would be:\n\n\n - Manufacturing<
/li>\n
- Quality Assurance
\n - Senior management
\n - Proje
ct Managers
\n - Qualified Persons (QPs)
\n - Regulatory
\
n - CMC Personnel
\n - Packaging Experts
\n - Business / Com
mercial functions
\n - Consultants
\n
\n\nDay 1 Schedule
\n\n
Lecture 1:\nU.S.\, EU and Japan GMPs - Status of
Harmonization and Where We'\;re Heading
\n\n\n - Cur
rent efforts to further harmonize GMP requirements
\n - Future expec
tation &\; likely progress
\n
\n\n
Lecture 2:\n
Where Inconsistencies Become a Problem: WHO\, ICH\, Countries
\n\n\n - Flexibility in global expectations
\n - Most challeng
ing topics where alignment varies
\n
\n\n
Lecture 3:\nKey Chapter Reviews
\n\n\n - ICH GMP organization\n
- Category reviews
\n
\n\n
Lecture 4:\nComp
liance with ICH Guidelines for GMPs
\n\n\n - Understandi
ng and Insight into Healthcare Authority expectations
\n - How GMP r
equirements / inspections can differ with a single ICH Standard
\n - How regulators (from 3 regions) will assess / enforce compliance with Q7<
/li>\n
\n\n
Lecture 5:\nGMP Comparisons for APIs
\n\n\n - Auditing API facilities
\n - Typical audit age
nda
\n - ICH Area differences
\n
\n\nDay 2 Schedule
\n\n
Lecture 1:\nGMP Comparisons for Finished Products
\n\n\n - Auditing finished product facilities
\n - Ty
pical audit agenda
\n - ICH Area differences
\n
\n\n
Le
cture 2:\nGMP Comparisons for .......
\n\n\n Active Ingredients\n - Finished products [drugs\, biologics]
\n - Excipient producers
\n - Sterile products
\n - OTC vs.
Prescription
\n - Implications for Contract Manufacturers
\n
\n\n
Lecture 3:\nDifferences on Area GMP Inspections
\n\n\n - Differences on how GMP inspections are conducted\n
- Areas of GMP inspection focus by area
\n - Modifying your s
elf-inspection systems to customized area concerns
\n
\n\n
Le
cture 4:\nOutsourcing Management......a Regional Perspective on
:
\n\n\n - Contract manufacturing
\n - Contract pa
ckaging
\n - 3rd \;Party Contract testing
\n
\n\n
Lecture 5:\nAuditing Your Facilities for Global Consi
derations
\n\n\n - Importance of pre-audits to regional
GMP focus
\n - How to focus your internal audits to a US\, EU and Ja
pan compliance system
\n
\n\n
Lecture 6:\nConclusi
ons / Wrap-Up
\n
\n \;
\n\nRobert Russell\nPresident / CEO \, RJR Consulting\, Inc. \;
\n \;\n
Rob
ert J. Russell (Bob) is President / CEO of RJR Consulting\, Inc. which spe
cializes in helping clients navigate through Global Regulatory Compliance
requirements for Pharmaceuticals\, Medical Devices\, Biologics\, Combinati
on Products and Dietary Supplement / OTC products. Prior to founding the c
ompany 17 years ago\, Bob had more than 27 years of experience in CMC\, Gl
obal Business development and Regulatory Affairs for two Fortune 200 firms
developing innovative Pharmaceuticals and Medical Devices.
\n\nBob
has specific expertise helping companies expand into new regions globally
and meet establishment and licensing requirements\, clinical trial data ex
pectations\, marketing authorization / registration preparation\, meet var
iations / amendment filing responsibilities and license renewal filings. H
e has practical experience counseling Pharmaceutical and Device manufactur
ers through GMP\, GCP\, GLP requirements\, CE marking / ISO certifications
\, Drug / Device Master File preparation\, mock pre-audits and issues mana
gement with Global Healthcare Authorities. Bob is a past member of the Int
ernational GMP Working Group on Standards for Industry harmonization with
several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
\n
\nPlease contact Marilyn Turner: Phone: +1 929 900 1853  \;E
mail: marilyn.turner [a] nyeventslist.com for registrations
\n
SUMMARY:US\, EU and Japan GMP Requirements: Practical ICH Area Differences\
, Healthcare Authority Inspection Focus
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SUMMARY:US\, EU and Japan GMP Requirements: Practical ICH Area Differences\
, Healthcare Authority Inspection Focus
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