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Best Practices to Withstand FDA Expectations (com) A

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TBA

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Philadelphia, PA 19102

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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

About this Event

*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***

REGISTER TODAY!

One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls.

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

Learning Objectives:

  • Regulatory requirements for SOPs
  • Legal requirements for SOP creation and maintenance
  • Types of SOPs
  • Formats and essential components of SOPs
  • How to effectively write an SOP to ensure compliance
  • SOP training and implementation
  • Deviations from and changes to SOPs

Seminar Fee Includes:

Lunch

AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

Who Will Benefit:

This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance:

  • Directors
  • Managers
  • Supervisors
  • Auditors
  • Regulatory operations
  • Clinical investigators, site management and contracting personnel
  • Clinical operations
  • Project managers
  • Data management
  • Medical writers
  • Compliance officers
  • Anyone required to create SOPs for their job function in a regulated industry

AGENDA

Day 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

9:00 – 10:00 – Overview of SOPs

Purpose

Determining need for SOP vs. working practices; standards; policies

Regulatory and legal requirements for development of SOPs

Processes that do not require SOPs

10:00 – 10:15 – Break

10:15 – 12:00 – SOP structure and creation

The foundational SOP template

SOP numbering system

Determining appropriate sections and content requirements

Determining level of detail

Developing a review and approval process

Developing a deviation process

Developing a change control process

Establishing timelines

12:00 – 12:45 – Lunch

12:45 – 2:15 – What SOPs need to be created

Preparing a list of SOPs by function

Resources for regulatory required SOPs

How to determine additional SOPs that will be required

2:15 – 2:30 – Break

2:30 – 3:30 - Writing an SOP

Essential Components of an SOP

Standardized definitions

Attaching references and template forms

Level of details to include: responsible person, function, task-by-task specificity for consistency

Documentation of task completion & compliance with SOP: Checklists, forms, reports

3:30 – 4:30 – Review of Inspection-cited deficiencies

Review inspection findings by regulatory agencies regarding SOP deficiencies

Discuss best practices and pitfalls to avoid deficiencies

Day 02(8:30 AM - 4:30 PM)

8:30 – 10:00 – Standard SOPs required for Key Drug Development Processes

Manufacturing

Clinical

Non-clinical

Regulatory

Compliance

Quality Assurance

10:00 – 10:15 - Break

10:15 – 12:00 – Outsourcing activities

SOPs required Internally to manage outsourcing

SOPs required for outsourced activities and verifying their acceptability

Availability of SOPs for review and reference

Changes to external SOPs and ongoing assessment

12:00 – 12:45 – Lunch

12:45 – 2:15 – Preparing the SOP

Using a process map to determine content and specificity for the organization

Standardizing style and tone

SOP control, distribution, obsoleting, revising

Prepare a sample SOP using an example provided

2:15 – 2:30 – Break

2:30 – 3:30 – SOP Communication and Training

Type of training for each SOP

Documentation of training

Conducting periodic reviews

Ongoing training requirements for updates and refreshers

Actions to take when SOPs are not followed: lack of training, deviations

3:30 – 4:30 – Preparing for Audits and Inspections

Coordinating audits

Providing SOPs for review

Addressing inspectional findings

SPEAKER

Peggy J. Berry

MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

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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