Online seminar Masters Program in GMPS Across The Phases Of Development

Peggy J Berry
Jun 3 - Jun 24 , 2020
Starting at

$1499


Jun 3 - Jun 24 , 2020
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Duration: 9Hrs 30 Mins  (2 Hrs./Day)              

No of modules: 4 modules (1 Module/Day/Week)

Dates: 

·     03rd June @11AM EST, 

·     10th June @11AM EST,

·     17th June @11AM EST,

·     24th June @11AM EST

Mode of delivery: Online

CEU: 9

 

Plianced brings Master programs, which allow learners to attend live classes, complete assignments at their convenience.
Regulatory compliance is increasingly visible in healthcare compliance, clinical research compliance, and quality and regulatory industries, including pharmaceutical, life sciences, food, and medical device industries.

ABOUT THE PROGRAM:

Early clinical trials are conducted to establish the initial safety of a drug.  The studies are generally in a small number of healthy subjects and use lower or ranging doses of the drug product.  Therefore, only small amounts of investigational material are required. In-order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early-stage investigational products to be manufactured under “phase 1 GMPs,” allowing flexibility in some of the rigorous, expensive, and time-consuming requirements.  As clinical development progresses, evolving into “phase 2 GMPs” and into commercialization with a methodical and comprehensive planned approach can save substantial time and expense.

This master program will include a detailed review of the current regulations as must be followed for commercialization as well as guidance documents with the flexibility in the interpretation of the regulations for earlier stages of manufacturing in compliance with GMPs to support early clinical trials.

Regulatory strategies, logistical considerations, and GMP-staging plans, options and alternatives, including raw material selection and receipt, vendor selection and management, stability programs, packaging and labelling, SOPs, documentation requirements, and validation will be discussed and explored through interpretations and case study examples.

PROGRAM OBJECTIVES:

Employ strategies within your company to save time and money in advancing clinical development.

This master program will provide the information and tools that you need to understand different baseline GMP requirements for each stage of development; beginning with needs for IND submission and phase 1 studies, progressing to phase 2, phase 3, NDA/BLA submission, and commercialization.

Options to explore and considerations for each will be discussed so that you have tools to develop and implement strategies for your organization using a phase-specific staging program of GMP requirements.

LEARNING METHODOLOGY:

Topic

Delivery mode

Presented By

Date

Time

Duration

Module 1:

Overall drug development and GMP timing

Live class

Plianced Expert

3rd June  2020

11.00 am ET

2 hrs

Q&A Session

15 mins

Module 2:

GMP regulations and interpretation for early stages Part 1

Q&A Session

Live class

Plianced Expert

10th June 2020

11.00 am ET

2 hrs

Q&A Session

15 mins

Module 3:

GMP regulations and interpretation for early stages Part 2

Live class

Plianced Expert

17th June 2020

11.00 am ET

2 hrs

Q&A Session

15 mins

Module 4:

Evolving processes to commercialization

Live class

Plianced Expert

24th June 2020

11.00 am ET

2 hrs

Q&A Session

 

 

 

 

15 mins

Online Assessment

Final assessment and certificate

Online test

 

 

 

30 mins

 

DETAIL COURSE CONTENT:

Module 1:

Overall drug development and GMP timing

-      Planning for the IND

-      Gaining feedback on GMP plans

-      Resource and product consideration in planning

-      Quality Unit and oversight

-      General GMP considerations for every stage/phase

Module 2:

GMP regulations and interpretation for early stages Part 1

-      Facility

-      Personnel

-      Equipment

-      SOPs

-      Documentation

Module 3:

GMP regulations and interpretation for early stages Part 2

-      Vendor selection, oversight, and management

-      Quality agreements and contracts

-      Auditing

-      Complaint handling

-      Change control

-      Investigations

-      SOPs internally and externally

-      Record review and batch release

-      Packaging and labeling

-      Updating the IND

 

Module 4:

Evolving processes to commercialization

-      Quality unit roles and responsibilities

-      Facility updates Change control

-      Preparing for the NDA/BLA

-      Validation plan

-      Master batch record

-      Electronic data collection

-      Packaging and labeling

-      Distribution

-      Instructions for use, storage, and handling

 

The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.

-            Moving a Product out of R&D

-            CMC Requirements for an IND Study and commercial

-            Good Manufacturing Practices: Basics for Beginners

-            Raw Material Management

Specifics topics include:

-            Issues with research-grade material used for laboratory and non-clinical testing

-            Optimizing manufacturing processes

-            Raw material requirements and process development

-            Assessing scalability of manufacturing

-            Planning the CMC for a potential IND

-            Study Essential elements of the CMC section of an IND

-            Characterization of the active ingredient and finished product

-            Various kinds of products: drugs, biologics, botanicals, diagnostics, medical device

-            Manufacturing facility personnel equipment and requirements

-            Core principles of GMP regulatory requirements for all different products… drugs to medical devices

-            Customizing regulatory compliance to a given product

-            Role of discussions with the FDA

-            Planning for the early stage with an eye toward large scale manufacturing

-            Vendor management

-            Raw material handling issues for early-stage products

-            Manufacturing step development

The following topics will be discussed to provide the requirements for early-stage products of different types and for vendor selection and management.

-            The scope of the FDA guidance documents

-            Acceptable practices and tips

-            GMP requirements for exploratory clinical studies

-            Specific requirements for drugs, biologics, and combination products

-            Specific issues for various kinds of combination products

-            Combination products with one or more new components

-            CMC issues for 505(b)(2) products

-            GMP and QSR: which to follow for a combination product

-            Introduction to process validation for early-stage manufacturers

-            Step by step introductions for process validation

-            Process validation reports and other documentation

-            Developing SOPs based on validation processes

-            Logistics of using contract manufacturing organizations for early-stage products

-            Pilot-scale manufacturing requirements GMP-grade and non-GMP grade manufacturing

-            Benefits and challenges with using local and international  vendors

Seminar (Price/Register)
Jun 3 - Jun 24 , 2020

Single Attendee


Group of 3 to 5 +1 Thumb Drive or 5 online Recorded version


Group of 6 to 10 +1 Thumb Drive or 10 online Recorded version

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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NY 10036

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Speaker: Peggy J Berry,

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career"(RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).


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