It is important for contract manufacturing operations, whether they are in the cosmetic, drug, or device industries to have a Quality Agreement in place. This webinar will teach you what a Quality Agreement is, why you need a Quality Agreement, where and when Quality Agreements are needed, and who should prepare, review, and approve a Quality Agreement.
WHY SHOULD YOU ATTEND?
Do you know what a Quality Agreement is? Do you know what should be included in a Quality Agreement? Do you know why you need a Quality Agreement? Do you know when a Quality Agreement is needed? Do you know who should prepare, review, and approve a Quality Agreement? Do you know what the responsibilities of the over vs. contract facility are? FDA is looking for Quality Agreements during inspections.
AREA COVERED
- What is a Quality Agreement?
- What should be included in a Quality Agreement?
- Why do you need a Quality Agreement?
- When is a Quality Agreement needed?
- Who should prepare, review, and approve a Quality Agreement?
- Responsibilities of the owner vs. contract manufacturer
- GMP responsibilities
WHO WILL BENEFIT?
- Quality Assurance
- External Manufacturing/Outsourcing
- Regulatory Affairs
- Compliance
- Purchasing
Do you know what a Quality Agreement is? Do you know what should be included in a Quality Agreement? Do you know why you need a Quality Agreement? Do you know when a Quality Agreement is needed? Do you know who should prepare, review, and approve a Quality Agreement? Do you know what the responsibilities of the over vs. contract facility are? FDA is looking for Quality Agreements during inspections.
- What is a Quality Agreement?
- What should be included in a Quality Agreement?
- Why do you need a Quality Agreement?
- When is a Quality Agreement needed?
- Who should prepare, review, and approve a Quality Agreement?
- Responsibilities of the owner vs. contract manufacturer
- GMP responsibilities
- Quality Assurance
- External Manufacturing/Outsourcing
- Regulatory Affairs
- Compliance
- Purchasing
Speaker Profile

John Misock is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. He provides regulatory consulting services across all FDA-regulated industries. John retired from FDA in June 2019 where he was an SME in microbiological compliance and manufacturing. Prior to FDA John served in a global capacity with a multinational company responsible for regulatory compliance in all manufacturing facilities. Early in his career, John was Director of a state Food, Drug, and Cosmetics program and also served as Assistant Commissioner of Agriculture.
Upcoming Webinars

CAPA/Root Cause Analysis: Achieving Compliance with Proper …



Risk and FDA Inspections: Anticipation, Preparation, Reacti…

Supervising a Human Error Free Environment: You can do a Lo…

Wage and Hour Compliance : Avoiding Stiff Penalties Under F…

The design was the leading cause of the most serious medica…


Data Integrity and Privacy: Compliance with 21 CFR Part 11,…

Non-Compete Agreements in the Workplace Will Be banned in 2…

Enhancing Employee Engagement to Drive Organizational Perfo…

FMLA: The law, challenges, and application



Effectively Controlling Conflict At Work: Practical Strateg…

Project Management for administrative professionals

All About Civility - Eliminating a Culture of Gossip Rumors…

AML Basics, Current Issues - Staying Compliant with the Reg…

Zero Acceptance Sampling to Reduce Inspection Costs

Implementing a Robust Change Control Program - Key Elements…

Exempt vs Non-Exempt Employees: Understand the Difference a…

3-Hour Excel Automation Boot Camp: Top Ten Excel Functions …


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Remote Deposit Capture (RDC): Rules and Regulations - Legal…

Estate, Gift, and Generation-Skipping Transfer Taxes


Accounting For Non Accountants : Debit, Credits And Financi…

New Pregnancy Protections Regulations in the Workplace for …

Employee Documentation: Are You Collecting and Retaining Re…