QUALITY AND GMP COMPLIANCE FOR VIRTUAL COMPANIES (PHARMACEUTICAL,
MEDICAL DEVICE & BIOLOGICS INDUSTRIES) Today, many COMPANIES OPERATE
ON AN OUTSOURCING MODEL. This is very common for COMPANIES WHO ARE
EVOLVING FROM BEING MAINLY DEVELOPMENT-focused to a point where they
are entering latter stages of Phase 2 or Phase 3 clinical trials, and
plan to have a product ready for market approval in the coming months.
Most such COMPANIES ARE SMALL, and may not have deep expertise in QA
and GMP COMPLIANCE, relying on their partners to cover those areas.
COMPANIES WHO OUTSOURCE THE MAJORITY OF OPERATIONS THROUGH THE USE OF
CONTRACT MANUFACTURING ORGANIZATIONS (CMOs), Contract Research
Organizations (CROs) and Contract Laboratories, however, remain
responsible for the QUALITY AND COMPLIANCE STATUS OF THE PRODUCTS THEY
SEND TO THE CLINIC OR TO THE MARKETPLACE. In this two day workshop
conference you will learn the requirements and expectations of major
health care regulators that are applicable to "VIRTUAL" COMPANIES. You
will learn how to diagnose your company's needs based on which GMP and
GCP-governed operations you retain and which you outsource; what the
current expectations and best industry practices are for selecting,
qualifying and monitoring your contractors to ensure they are meeting
your requirements; and how to build a QUALITY SYSTEM FRAMEWORK THAT IS
NOT EXCESSIVE FOR YOUR CURRENT NEEDS, but has the structure and
integration to "grow with you" as the scope your operations change in
the coming months and years. You will also learn best practices for
managing a regulatory inspection, with emphasis on FDA, EMA and Health
Canada, but applicable to most other major agencies as well. Learning
Objectives: Participants in this seminar will: Understand the GMP and
GCP requirements all VIRTUAL COMPANIES MUST MEET REGARDLESS OF THE
EXTENT OF THEIR OUTSOURCING OPERATIONS UNDERSTAND HOW TO SELECT,
qualify and monitor CMOs, CROs and Contract Laboratories Learn the
elements to include in a QUALITY AGREEMENT (also known as a technical
agreement) Learn how to determine which GMP or GCP requirements apply
to you, depending on the things you do internally and those you
outsource Understand your obligations under the law for products you
release to the clinic or the marketplace Appreciate the importance of
maintaining data integrity Learn how to effectively manage a health
regulatory inspection: Inspection logistics Responding effectively to
document requests and questions from inspectors Managing the
inspection exit discussion How to write an effective response to
inspection observations How to find applicable inspection references
and procedures of the FDA, EMA and Health Canada Who will Benefit:
This course is designed for those charged with managing QUALITY
ASSURANCE AND REGULATORY AFFAIRS FOR COMPANIES IN THE DEVELOPMENT OR
COMMERCIAL PHASE OF GROWTH WHO EITHER RELEASE INVESTIGATIONAL DRUGS TO
CLINICAL TRIAL SITES OR SEND COMMERCIAL PRODUCTS TO THE MARKET, but
rely to a great extent on the use of Contract Manufacturers and/or
Contract Laboratories. The following personnel will benefit from the
course: Senior QUALITY MANAGERS IN MANUFACTURING QA/GMP or clinical
QUALITY AREAS QUALITY PROFESSIONALS REGULATORY PROFESSIONALS CLINICAL
OPERATIONS COMPLIANCE PROFESSIONALS QUALITY AUDITORS – GMP and GCP
Document control specialists For Registration:
https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa-for-virtual-companies-seminar-training-80445SEM-prdsmchannel=ticketleap
[https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa-for-virtual-companies-seminar-training-80445SEM-prdsm?channel=ticketleap]
Seminar One Registration - $2099.00 Cost: 2099.00 Categories: Other &
Miscellaneous
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21/02/2020 Last update